A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
1. Are males or females, 2. Are at least 18 years of age, 3. Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males and females.
At least 18 years of age
Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Disqualifiers
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 or hepatitis C.
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.
Trial design
Design model
Crossover
Treatments tested in this trial
PF-08049820
DrugAdministered orally
Rabeprazole
DrugAdministered orally
Treatment groups
24 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Sequence 1 (Part A)Experimental treatment 1 intervention
Group B: Sequence 2 (Part A)Experimental treatment 1 intervention
Group C: Sequence 3 (Part A)Experimental treatment 1 intervention
Group D: Sequence 4 (Part A)Experimental treatment 1 intervention
Group E: Sequence 5 (Part A)Experimental treatment 1 intervention
Group F: Sequence 6 (Part A)Experimental treatment 1 intervention
Group G: Sequence 7 (Optional Part B)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Time frame
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B2
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Time frame
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B3
Maximum observed plasma concentration (Cmax)
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Time frame
Baseline up to Day 16 for Part A and up to Day 24 for optional Part BSecondary outcomes
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Part A and optional Part B
Time frame
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B2
Number of Participants With Serious Adverse Events (SAEs)
Part A and optional Part B
Time frame
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B3
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Part A and optional Part B
Time frame
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B4
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Part A and optional Part B
Time frame
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B Source ClinicalTrials.gov