- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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).
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Luoghi di studio
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06511
- Reclutamento
- Pfizer Clinical Research Unit - New Haven
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: 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).
|
|
Comparatore placebo: 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).
|
|
Altro: 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)
|
|
Altro: 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)
|
|
Comparatore placebo: 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).
|
|
Altro: 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.
|
Sciroppo orale
Oral suspension (Parts A to F); Tablets (Parts C and F only)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: Up to Day 36
|
Part C: Cohort 9
|
Up to Day 36
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Up to Day 36
|
Part D: Cohort 10 (optional)
|
Up to Day 36
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Up to Day 51
|
Part F: Cohort 13 (optional)
|
Up to Day 51
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità, immediata
- Ipersensibilità
- Asma
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Benzazepine
- Benzodiazepine
- Midazolam
Altri numeri di identificazione dello studio
- C6611001
- 2026-526260-21-00 (Identificatore di registro: CTIS (EU))
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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