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HMG-CoA Reductase Inhibitor

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

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 study day -1 (d-1) (ie, period 1 day-1 [p1d-1]), d6 (p2d1), d13 (p2d8), d20 (p2d15), d27 (p2d22), d37 (p3d1), d42 (p4d1), d50 (p4d9), d60 (p4d19), d66 (p5d6), and at follow-up visit (days 72-75) of part b.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, PF-06882961, to see how it affects the body's handling of two other drugs in healthy adults and postmenopausal women. Researchers want to know if PF-06882961 changes how quickly or effectively the body uses atorvastatin and midazolam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day -1 (d-1) (ie, period 1 day-1 [p1d-1]), d6 (p2d1), d13 (p2d8), d20 (p2d15), d27 (p2d22), d37 (p3d1), d42 (p4d1), d50 (p4d9), d60 (p4d19), d66 (p5d6), and at follow-up visit (days 72-75) of part b.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day -1 (d-1) (ie, period 1 day-1 [p1d-1]), d6 (p2d1), d13 (p2d8), d20 (p2d15), d27 (p2d22), d37 (p3d1), d42 (p4d1), d50 (p4d9), d60 (p4d19), d66 (p5d6), and at follow-up visit (days 72-75) of part b.

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day -1 (d-1) (ie, period 1 day-1 [p1d-1]), d6 (p2d1), d13 (p2d8), d20 (p2d15), d27 (p2d22), d37 (p3d1), d42 (p4d1), d50 (p4d9), d60 (p4d19), d66 (p5d6), and at follow-up visit (days 72-75) of part b. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Part A) AUCinf of Midazolam in Periods 2, 5, and 8

(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7

(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5

+1 more

Secondary study objectives

(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)

(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)

+11 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

Headache

Dyspepsia

Abdominal distension

Eructation

Decreased appetite

Hypoglycaemia

Abdominal pain upper

Constipation

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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