Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Study Details
Study Description
Brief Summary
A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This study is designed to look at the effect of two doses of PF 06882961 (120 milligram (mg) twice a day (BID) and 200 mg BID) on the levels of one dose of rosuvastatin 10 mg and one dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. Total duration of study from screening to the telephone visit will be approximately 17 weeks, of which up to 63 days will be inpatient. All subjects take (i) Rosuvastatin alone, Midazolam alone, PF 06882961 alone (120 mg BID), PF 06882961 (120 mg BID) + Rosuvastatin, PF 06882961 (120 mg BID) + Midazolam, PF 06882961 (200 mg BID) alone, PF 06882961 (200 mg BID) + Rosuvastatin, PF 06882961 (200 mg BID)+ Midazolam in the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Period 1 Participants will receive the following treatments in this sequence : (i)Rosuvastatin alone (one dose of 10 mg), (ii) Midazolam alone (one dose of 2mg), (iii) PF 06882961 alone (120 mg twice daily), (iv) PF 06882961 (120 mg twice daily) + Rosuvastatin (one dose of 10mg), (v) PF 06882961 (120 mg) + Midazolam (one dose of 2 mg), (vi) PF 06882961 (200 mg) alone, (vii) PF 06882961 (200 mg) + Rosuvastatin (one dose of 10 mg), (viii) PF 06882961 (200 mg)+ Midazolam (one dose of 2 mg) in the study. |
Drug: PF-06882961
120 mg and 200 mg BID
Drug: Rosuvastatin
10 mg single dose
Drug: Midazolam
2mg single dose
|
Outcome Measures
Primary Outcome Measures
- Effects of PF 06882961 on Rosuvastatin plasma pharmacokinetic parameter AUCinf (if data permits otherwise AUClast) [0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours post dose on Day 1 at Periods 1, 4 and 7]
Rosuvastatin plasma pharmacokinetic parameters: AUCinf (if data permits otherwise AUClast) in Periods 1, 4 and 7.
- Effects of PF 06882961 on midazolam pharmacokinetic parameter AUCinf (if data permits otherwise AUClast) [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose on Day 1 at Periods 2, 5 and 8]
Midazolam plasma pharmacokinetic parameters: AUCinf (if data permits otherwise AUClast) in Periods 2, 5 and 8
Secondary Outcome Measures
- Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) [From baseline to up to 35 days after last dose for a total of approximately 96 days]
- Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality [From baseline to up to 10 days after last dose for a total of approximately 71 days]
- Number of Participants With Abnormal Vital Signs [From baseline to up to 10 days after last dose for a total of approximately 71 days]
- Change from baseline in body weight [From baseline to up to 10 days after last dose for a total of approximately 71 days]
- Number of Participants With Abnormal Electrocardiogram (ECG) Interval [From baseline to up to 10 days after last dose for a total of approximately 71 days]
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [From baseline to up to 10 days after last dose for a total of approximately 71 days]
- Number of Participants with categorical scores on the Patient Health Questionnaire (PHQ-9) [From baseline to up to 10 days after last dose for a total of approximately 71 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.
-
Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening
Exclusion Criteria:
-
Known prior participation in a trial involving PF-06882961.
-
Known intolerance or hypersensitivity to GLP-1R agonists.
-
Known hypersensitivity to rosuvastatin or midazolam.
-
Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. Note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria
-
Any lifetime history of a suicide attempt.
-
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
-
Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3421007