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

NCT04621227

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021
ClinicalTrials.g[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A PHASE 1, OPEN -LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ROSUVASTATIN AND MIDAZOLAM IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OBESITY
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: PF-06882961
    120 mg and 200 mg BID
  • Drug: Rosuvastatin
    10 mg single dose
  • Drug: Midazolam
    2mg single dose
Study Arms  ICMJE 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.
Interventions:
  • Drug: PF-06882961
  • Drug: Rosuvastatin
  • Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 21, 2021
Estimated Primary Completion Date April 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04621227
Other Study ID Numbers  ICMJE C3421007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP