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Single dose of PF-07104091 as Tablet Formulation D (Treatment D) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Awards & highlights

Study Summary

This trial is testing a new drug to see how it is changed and eliminated from the body, and how this is affected by different tablet formulations and whether the dose is given under fasted or fed conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C
Secondary outcome measures
AUCinf of PF-07104091 for Treatment C, D and E
Cmax of PF-07104091 for Treatment C, D and E
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments
+4 more

Side effects data

From 2022 Phase 1 trial • 30 Patients • NCT05431153
90%
Nausea
21%
Vomiting
17%
Diarrhoea
10%
Dizziness
10%
Headache
7%
Chills
7%
Eructation
3%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Treatment D: PF-07104091 Tablet Formulation D (Fasted)

Trial Design

6Treatment groups
Experimental Treatment
Group I: PF-07104091 Sequence 6Experimental Treatment4 Interventions
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
Group II: PF-07104091 Sequence 5Experimental Treatment4 Interventions
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
Group III: PF-07104091 Sequence 4Experimental Treatment4 Interventions
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
Group IV: PF-07104091 Sequence 3Experimental Treatment4 Interventions
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
Group V: PF-07104091 Sequence 2Experimental Treatment4 Interventions
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
Group VI: PF-07104091 Sequence 1Experimental Treatment4 Interventions
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
2022
Completed Phase 1
~30
Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
2022
Completed Phase 1
~30
Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
2022
Completed Phase 1
~30
Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
2022
Completed Phase 1
~30
Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,908,020 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,089,188 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
2022. "A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05431153.
~11 spots leftby Apr 2025
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