PF-07104091 Sequence 2 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New Haven Clinical Research Unit, New Haven, CT
Healthy Subjects (HS)
Single dose of PF-07104091 as Tablet Formulation D (Treatment D) - Drug
Eligibility
18 - 65
Male
What conditions do you have?
Select

Study Summary

This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Hour 48
AUCinf of PF-07104091 to estimate the bioavailability of Tablet Formulation D
AUCinf of PF-07104091 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of Tablet Formulation C
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07104091 to estimate relative bioavailability of Tablet Formulations A, B, and C
Cmax if PF-07104091 to estimate the bioavailability of Tablet Formulation D
Cmax of PF-07104091 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of Tablet Formulation C
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 to estimate relative bioavailability of Tablet Formulation A, B, and C
Day 28
Number of Participants With Abnormalities in Physical Examination
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants With Laboratory Abnormalities

Trial Safety

Trial Design

6 Treatment Groups

PF-07104091 Sequence 2
1 of 6
PF-07104091 Sequence 5
1 of 6
PF-07104091 Sequence 6
1 of 6
PF-07104091 Sequence 3
1 of 6
PF-07104091 Sequence 4
1 of 6
PF-07104091 Sequence 1
1 of 6
Experimental Treatment

30 Total Participants · 6 Treatment Groups

Primary Treatment: PF-07104091 Sequence 2 · No Placebo Group · Phase 1

PF-07104091 Sequence 2Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation D (Treatment D), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug
PF-07104091 Sequence 5Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation C (Treatment E), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug
PF-07104091 Sequence 6Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation C (Treatment E), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug
PF-07104091 Sequence 3Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation D (Treatment D), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug
PF-07104091 Sequence 4Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation C (Treatment E), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug
PF-07104091 Sequence 1Experimental Group · 4 Interventions: Single dose of PF-07104091 as Tablet Formulation D (Treatment D), Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Closest Location: New Haven Clinical Research Unit · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
2015First Recorded Clinical Trial
41 TrialsResearching Healthy Subjects (HS)
47 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Male Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male and you are not overtly unhealthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.