- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06511
- Rekruttering
- Pfizer Clinical Research Unit - New Haven
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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).
|
|
Andet: 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)
|
|
Andet: 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).
|
|
Andet: 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.
|
Oral sirup
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to Day 36
|
Part D: Cohort 10 (optional)
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to Day 51
|
Part F: Cohort 13 (optional)
|
Up to Day 51
|
|
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Luftvejssygdomme
- Lungesygdomme
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Respiratorisk overfølsomhed
- Overfølsomhed, Øjeblikkelig
- Overfølsomhed
- Astma
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Benzazepiner
- Benzodiazepiner
- Midazolam
Andre undersøgelses-id-numre
- C6611001
- 2026-526260-21-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Midazolam
-
Diskapi Yildirim Beyazit Education and Research...Ikke rekrutterer endnuPædiatrisk anæstesi | PræmedicineringTyrkiet (Türkiye)
-
SYED HAIDER ALIIkke rekrutterer endnuSedation og Smertebehandling hos Patienter, der Underkaster sig Fleksibel Bronkoskopi
-
University of Tennessee Graduate School of MedicineAfsluttetSedation | VasektomiForenede Stater
-
Benha UniversityRekrutteringSmertebehandling | Kroniske rygsmerter | Postoperative akutte smerterEgypten
-
Zhuji People's Hospital of Zhejiang ProvinceAfsluttetKejsersnit | Effektivitet | Sikkerhed | Præeklampsi | MidazolamKina
-
Seattle Children's HospitalAfsluttet
-
Sohag UniversityIkke rekrutterer endnu
-
Ganzhou Hemay Pharmaceutical Co., LtdAfsluttet
-
Jiangsu HengRui Medicine Co., Ltd.Afsluttet