A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961

NCT03492697 | Completed Phase 1 FDA Drug

• 1 other identifier: C3421003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax) for PF-06882961

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)

  24 hours post dose in each period

• Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Apparent clearance (CL/F) for PF-06882961, as data permit

  Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

• Peak-to-trough (PTR) ratio for PF-06882961

  Calculated as ratio of Cmax to C24

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Secondary Outcomes (7)

• Number of subjects with treatment-emergent adverse events (AEs)

  Baseline to at least 28 days after last dose

• AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

• AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

• Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

• AUClast for PF-06882961 for CR tablet (long) in fed and fasted states

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

Study Arms (1)

PF-06882961

EXPERIMENTAL

Drug: PF-06882961 Immediate Release Tablet; Drug: PF-06882961 Controlled Release Tablet (long); Drug: PF-06882961 Controlled Release Tablet (short); Drug: PF-06882961 Immediate Release Solution

Interventions

PF-06882961 Immediate Release Tablet DRUG

Immediate Release Tablet

PF-06882961

PF-06882961 Controlled Release Tablet (long) DRUG

Controlled Release tablet (long)

PF-06882961

PF-06882961 Controlled Release Tablet (short) DRUG

Controlled Release tablet (short)

PF-06882961

PF-06882961 Immediate Release Solution DRUG

PF-06882961 Immediate Release solution

PF-06882961

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, inclusive
• Body mass index (BMI) within 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 indicating that the subject has been informed of all pertinent aspects of the study

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), 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 7 drinks/week for female subjects or 14 drinks/week for male subjects within 6 months before screening.
• 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).
• Subjects who have previously participated in prior studies with PF 06882961 as the investigational product.
• 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 QTc interval \>450 msec or a QRS interval \>120 msec.
• Aspartate aminotransferase (AST) level \>= 1.25 × upper limit of normal (ULN);
• Alanine aminotransferase (ALT) level \>= 1.25 × ULN;
• Total bilirubin level \>=1.5 × ULN;
• TSH \> ULN;
• HbA1c \>=6.5%.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for at least 28 days after the last dose of investigational product.
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

danuglipron

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: April 3, 2018
• First Posted: April 10, 2018
• Study Start: April 30, 2018
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)