Drug-Drug Interaction Study to Evaluate the Effect of PF-06865571 on Metformin Pharmacokinetics

NCT03593707 | Completed Phase 1 FDA Drug

• 2 other identifiers: C25410062018-001888-23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the effect of PF-06865571 administration on the pharmacokinetics of metformin in healthy adult subjects.

Conditions

Healthy Volunteers

Keywords

PF-06865571; Metformin; Drug-drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of Metformin (in absence of PF-06865571)

  Metformin Cmax in absence of PF-06865571

  0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose

• Metformin Cmax (in presence of PF-06865571)

  Metformin Cmax in presence of PF-06865571

  0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Metformin (in absence of PF-06865571)

  Metformin AUCinf in absence of PF-06865571

  0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose

• Metformin AUCinf (in presence of PF-06865571)

  Metformin AUCinf in presence of PF-06865571

  0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Baseline up to 35 days after last dose of study medication

• Number of Participants With Laboratory Abnormalities

  Baseline up to 35 days after last dose of study medication

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  0 and 48 hours (h) post-dose

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

  0 and 48 h post-dose

Study Arms (2)

Metformin Alone

EXPERIMENTAL

Metformin alone

Drug: Metformin

Metformin + PF-06865571

EXPERIMENTAL

Co-administer metformin and PF-06865571

Drug: Metformin; Drug: PF-06865571

Interventions

Metformin DRUG

Metformin

Also known as: Glucophage

Metformin + PF-06865571; Metformin Alone

PF-06865571 DRUG

PF-06865571

Metformin + PF-06865571

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years.
• Body mass index of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
• Evidence of a personally signed and dated informed consent document.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug test.
• History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
• Screening supine BP \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec.
• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>=1.25× upper limit of normal (ULN);
• Total bilirubin level \>=1.5× ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<=ULN.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and through the follow up contact, or have female partners that are pregnant.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is used to flush any intravenous catheters in the study.
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing at the screening visit for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). While not part of the tests assessed in this study, subjects with a positive hepatitis B surface antibody (HepBsAb) result due to vaccination are deemed eligible.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Metformin; ervogastat

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: August 17, 2018
• Primary Completion: January 17, 2019
• Study Completion: February 13, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)