- ICH GCP
- Registr klinických studií v USA
- Klinická 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).
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Pfizer CT.gov Call Center
- Telefonní číslo: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studijní místa
-
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Connecticut
-
New Haven, Connecticut, Spojené státy, 06511
- Nábor
- Pfizer Clinical Research Unit - New Haven
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: 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).
|
|
Komparátor placeba: 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).
|
|
Jiný: 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)
|
|
Jiný: 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)
|
|
Komparátor placeba: 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).
|
|
Jiný: 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.
|
Orální sirup
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Časové okno: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Up to Day 36
|
Part D: Cohort 10 (optional)
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: Up to Day 51
|
Part F: Cohort 13 (optional)
|
Up to Day 51
|
|
Number of Participants With Serious Adverse Events (SAEs)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Nemoci dýchacích cest
- Plicní onemocnění
- Bronchiální onemocnění
- Plicní onemocnění, obstrukční
- Respirační přecitlivělost
- Přecitlivělost, okamžitá
- Přecitlivělost
- Astma
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Benzazepiny
- Benzodiazepiny
- Midazolam
Další identifikační čísla studie
- C6611001
- 2026-526260-21-00 (Identifikátor registru: CTIS (EU))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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