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HMG-CoA Reductase Inhibitor

PF-06882961 for Healthy Adults

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b, periods 1, 3 and 5 @ 0 hr and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Awards & highlights

Study Summary

This study is evaluating whether a drug called PF-06882961 can improve the PK of other drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b, periods 1, 3 and 5 @ 0 hr and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and part b, periods 1, 3 and 5 @ 0 hr and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 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
AUCinf, as data permit, otherwise AUClast.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUCinf), as data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Secondary outcome measures
Change from Baseline in Modified Body Mass Index (mBMI) at Month X
Incidence of treatment emergent Electrocardiogram (ECG) abnormalities
Incidence of treatment emergent clinical laboratory abnormalities
+4 more

Side effects data

From 2021 Phase 2 trial • 151 Patients • NCT04617275
25%
Vomiting
20%
Nausea
10%
Urinary tract infection
10%
Gastrooesophageal reflux disease
10%
Dizziness
10%
Abdominal pain
10%
Diarrhoea
5%
Dyspepsia
5%
Headache
5%
Abdominal distension
5%
Eructation
5%
Decreased appetite
5%
Hypoglycaemia
5%
Abdominal pain upper
5%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06882961 80 mg BID Low, Slow (T2DM)
PF-06882961 80 mg BID High, Slow (T2DM)
PF-06882961 120 mg BID Low, Fast (T2DM)
PF-06882961 120 mg BID High, Fast (T2DM)
PF-06882961 200 mg BID (T2DM)
PF-06882961 200 mg BID (Non-diabetic Obesity)
Placebo (T2DM)
Placebo (Non-diabetic Obesity)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment2 Interventions
To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of an Oral Contraceptive (Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg tablet).
Group II: Part AExperimental Treatment3 Interventions
To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of atorvastatin (20 mg tablet) and midazolam (5 mg syrup).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900
PF-06882961
2018
Completed Phase 2
~800
Midazolam
2018
Completed Phase 4
~1910
Levonorgestrel & Ethinyl Estradiol
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,443 Total Patients Enrolled
1 Trials studying Healthy Adults
37 Patients Enrolled for Healthy Adults
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,557 Total Patients Enrolled
1 Trials studying Healthy Adults
37 Patients Enrolled for Healthy Adults

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
2021. "STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093205.
~10 spots leftby Apr 2025
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