- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07660731
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND/OR ADULTS WITH MILD TO MODERATE ASTHMA
The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.
For Parts A, B, C, D and F, the study is seeking participants who:
- Are healthy (do not have disease) males or females who can no longer have children,
- Are 18 to 65 years old,
- Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight
For Part A (optional group or cohort 3: Japanese participants only):
- A body weight of more than 45 kilograms (100 pounds).
- Have 4 biological Japanese grandparents who were born in Japan.
For Part E only:
- Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.
- Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).
The study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:
- how the body processes the study medicine in healthy participants (Parts A and B),
- how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),
- how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),
- how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),
- if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).
Participants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).
During this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.
Study measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studienorte
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06511
- Rekrutierung
- Pfizer Clinical Research Unit - New Haven
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Key Inclusion criteria (Parts A, B, C, D and F):
- Are males or females who can no longer have children,
- Are 18 to 65 years old,
- Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).
For Part A (Optional group or cohort 3: Japanese participants only):
- A total body weight of more than 45 kg (100 pounds).
- Have 4 biological Japanese grandparents who were born in Japan.
For Part E only:
Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.
1. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).
Key Exclusion criteria
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Any history of parasitic infection requiring treatment within 28 days prior to screening.
- Positive tuberculosis infection test result.
- Part C only: Evidence or history of conditions interfering with the ability to taste.
- Part D only: History of irregular bowel movements.
- Part E only: Evidence of lung disease(s) other than asthma.
- Part E only: Asthma exacerbation within 3 months prior to screening.
- Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Part A: Cohorts 1, 2 and Optional Cohort 3
PF-08103402 as suspension or matching placebo as a single oral dose on Day 1 of each period
|
Oral suspension (Parts A to F); Tablets (Parts C and F only)
Oral suspension (Parts A, B and E).
|
|
Placebo-Komparator: Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8
PF-08103402 as suspension or matching placebo given once daily oral doses from Day 1 through Day 14.
|
Oral suspension (Parts A to F); Tablets (Parts C and F only)
Oral suspension (Parts A, B and E).
|
|
Sonstiges: Part C: Cohort 9
PF-08103402 as a single oral dose as suspensions or tablets on Day 1 of each period
|
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
|
Sonstiges: Part D: Cohort 10 (Optional)
PF-08103402 as a single oral dose as suspension on Day 1.
|
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
|
Placebo-Komparator: Part E: Cohorts 11 (Optional) and 12 (Optional)
PF-08103402 as suspension or corresponding placebo as oral doses from Day 1 through Day 14.
|
Oral suspension (Parts A to F); Tablets (Parts C and F only)
Oral suspension (Parts A, B and E).
|
|
Sonstiges: Part F: Cohort 13 (Optional)
Period 1: Single oral dose of midazolam on Day 1. Period 2: Once daily oral dose of PF-08103402 as suspension or tablet from Day 1 through Day 14 and a single oral dose of midazolam on Day 14.
|
Oraler Sirup
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Parts A: Up to Day 36; Part B and E: Up to Day 50
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
Part E: Cohorts 11 (optional) and 12 (optional)
|
Parts A: Up to Day 36; Part B and E: Up to Day 50
|
|
Number of Participants with Serious Adverse Events (SAEs)
Zeitfenster: Parts A: Up to Day 36; Part B and E: Up to Day 50
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
Part E: Cohorts 11 (optional) and 12 (optional)
|
Parts A: Up to Day 36; Part B and E: Up to Day 50
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Zeitfenster: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
Part E: Cohorts 11 (optional) and 12 (optional)
|
Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Zeitfenster: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
Part E: Cohorts 11 (optional) and 12 (optional).
|
Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Zeitfenster: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
Part E: Cohorts 11 (optional) and 12 (optional).
|
Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1
|
Part C: Cohort 9
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1
|
|
Maximum observed plasma concentration (Cmax) in the fasted state
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1
|
Part C: Cohort 9
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1
|
|
Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered
Zeitfenster: Pre-dose (Hour 0) and at 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
Part D: Cohort 10 (optional)
|
Pre-dose (Hour 0) and at 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
|
Time of Maximum observed plasma concentration (Tmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
Part A: Cohorts 1, 2 and Cohort 3 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
|
Half-life (t½) if data permit
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
Part A: Cohorts 1, 2 and Cohort 3 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
|
|
Area under the curve over 1 dosing interval (AUCtau)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
|
Time of Maximum observed plasma concentration (Tmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
|
Half-life (t½) if data permit
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14
|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Zeitfenster: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Zeitfenster: Change From Baseline to Day 4
|
Part C: Cohort 9
|
Change From Baseline to Day 4
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Zeitfenster: Change From Baseline to Day 4
|
Part C: Cohort 9
|
Change From Baseline to Day 4
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Zeitfenster: Change From Baseline to Day 4
|
Part C: Cohort 9
|
Change From Baseline to Day 4
|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Up to Day 36
|
Part D: Cohort 10 (optional)
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Zeitfenster: Up to Day 36
|
Part D: Cohort 10 (optional)
|
Up to Day 36
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Zeitfenster: Change From Baseline to Day 11
|
Part D: Cohort 10 (optional)
|
Change From Baseline to Day 11
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Zeitfenster: Change From Baseline to Day 11
|
Part D: Cohort 10 (optional)
|
Change From Baseline to Day 11
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Zeitfenster: Change From Baseline to Day 11
|
Part D: Cohort 10 (optional)
|
Change From Baseline to Day 11
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7)
|
Part D: Cohort 10 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7)
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7).
|
Part D: Cohort 10 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7).
|
|
Change From Baseline (CFB) in Fractional concentration of exhaled Nitric Oxide (FeNO) at Day 14
Zeitfenster: Pre-dose (Hour 0) and at 72 hours post-dose (Day 4), 144 hours post-dose (Day 7), 264 hours post-dose (Day 12), 312 hours post-dose (Day 14) and 384 hours post-dose (Day 17)
|
Part E: Cohorts 11 (optional) and 12 (optional)
|
Pre-dose (Hour 0) and at 72 hours post-dose (Day 4), 144 hours post-dose (Day 7), 264 hours post-dose (Day 12), 312 hours post-dose (Day 14) and 384 hours post-dose (Day 17)
|
|
Area under the curve over 1 dosing interval (AUCtau)
Zeitfenster: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
Part E: Cohorts 11 (optional) and 12 (optional)
|
Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
Part E: Cohorts 11 (optional) and 12 (optional)
|
Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
|
Time of Maximum observed plasma concentration (Tmax)
Zeitfenster: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
Part E: Cohorts 11 (optional) and 12 (optional)
|
Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
|
Half-life (t½) if data permit
Zeitfenster: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
Part E: Cohorts 11 (optional) and 12 (optional)
|
Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Up to Day 51
|
Part F: Cohort 13 (optional)
|
Up to Day 51
|
|
Number of Participants With Serious Adverse Events (SAEs)
Zeitfenster: Up to Day 51
|
Part F: Cohort 13 (optional)
|
Up to Day 51
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Zeitfenster: Change From Baseline to Day 16
|
Part F: Cohort 13 (optional)
|
Change From Baseline to Day 16
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Zeitfenster: Change From Baseline to Day 16
|
Part F: Cohort 13 (optional)
|
Change From Baseline to Day 16
|
|
Area under the curve over 1 dosing interval (AUCtau)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
|
Time of Maximum observed plasma concentration (Tmax)
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
|
Half-life (t½) if data permit
Zeitfenster: Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
Part F: Cohort 13 (optional)
|
Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Erkrankungen der Atemwege
- Lungenkrankheit
- Bronchialerkrankungen
- Lungenerkrankungen, obstruktive
- Überempfindlichkeit der Atemwege
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Asthma
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Benzazepines
- Benzodiazepine
- Midazolam
Andere Studien-ID-Nummern
- C6611001
- 2026-526260-21-00 (Registrierungskennung: CTIS (EU))
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Klinische Studien zur Asthma
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Meyer Children's Hospital IRCCSRekrutierungAsthma bei Kindern | Asthma akut | Asthmakrise | Asthma-KindheitItalien
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Columbia UniversityChildren's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... und andere MitarbeiterNoch keine RekrutierungAkute Asthma | Pädiatrisches Asthma | Nicht-invasive Überdruckbeatmung | BiPAPVereinigte Staaten
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Vanderbilt University Medical CenterZurückgezogenAsthma bei Kindern | Asthmaanfall | Asthma akut | Akute Asthma-Exazerbation | Asthma; StatusVereinigte Staaten
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Noch keine RekrutierungAnhaltendes Asthma | Asthma (Diagnose) | Moderate Asthma-ExazerbationVereinigte Staaten
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Massachusetts General HospitalRekrutierungAsthma | Asthma-Exazerbation | Asthma-Kontrollniveau | Asthma akutVereinigte Staaten
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University of PittsburghNational Institute of Environmental Health Sciences (NIEHS)RekrutierungAsthma-Exazerbation | Asthma im Kindesalter | Luftverschmutzung, Verhaltensweisen zur Risikominderung | AsthmakontrolleVereinigte Staaten
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Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Noch keine Rekrutierung
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Henan University of Traditional Chinese MedicineNoch keine Rekrutierung
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Hospices Civils de LyonAktiv, nicht rekrutierend
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Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentRekrutierungSchweres Asthma | Asthma-Exazerbationen | Bronchiale ThermoplastikNiederlande
Klinische Studien zur Midazolam
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Diskapi Yildirim Beyazit Education and Research...Noch keine RekrutierungPädiatrische Anästhesie | PrämedikationTürkei (türkiye)
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SYED HAIDER ALINoch keine RekrutierungSedierung und Analgesiemanagement bei Patienten, die sich einer flexiblen Bronchoskopie unterziehen
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PfizerAbgeschlossenGesunder FreiwilligerVereinigte Staaten
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Benha UniversityRekrutierungSchmerztherapie | Chronische Rückenschmerzen | Postoperativer akuter SchmerzÄgypten
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Zhuji People's Hospital of Zhejiang ProvinceAbgeschlossenKaiserschnitt | Wirksamkeit | Sicherheit | Präeklampsie | MidazolamChina
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Seattle Children's HospitalAbgeschlossen
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Sohag UniversityNoch keine RekrutierungVitreoretinale ChirurgieÄgypten
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Cumhuriyet UniversityAbgeschlossenPostoperatives DeliriumTürkei (türkiye)
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Postgraduate Institute of Dental Sciences RohtakAnmeldung auf Einladung
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Jiangsu HengRui Medicine Co., Ltd.AbgeschlossenGicht und HyperurikämieChina