Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571

NCT03092232 | Completed Phase 1 FDA Drug

• 1 other identifier: C2541001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events (AEs)

  Number of participants with reported adverse events

  Screening up to 35 days after last dose of study medication

• Number of subjects with laboratory tests findings of potential clinical importance

  Number of participants with potentially clinically important laboratory test findings

  Baseline (Day 0) up to 14 days after last dose of study medication

• Number of subjects with vital signs findings of potential clinical importance

  Number of participants with potentially clinically important vital sign measurements

  Baseline (Day 0) up to 14 days after last dose of study medication

• Number of subjects with electrocardiogram (ECG) findings of potential clinical importance

  Number of participants with potentially clinically important ECG findings

  Baseline (Day 0) up to 14 days after last dose of study medication

Secondary Outcomes (10)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period

• Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period

• Dose normalized AUClast for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period

• Dose normalized AUCinf for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period

• Maximum Observed Plasma Concentration (Cmax) for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period

Study Arms (3)

Cohort 1_Active and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 2_Active and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 3_Active and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Interventions

PF-06865571 DRUG

Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 5 mg, 50 mg, 500 mg, TBD (to be determined)/2000 mg.

Cohort 1_Active and Matching Placebo

Placebo DRUG

Matching Placebo for PF-06865571 for each cohort.

Cohort 1_Active and Matching Placebo; Cohort 2_Active and Matching Placebo; Cohort 3_Active and Matching Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males and female of non-childbearing potential;
• Age of 18-55, inclusive;
• Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
• Body weight \>50 kg;
• Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

You may not qualify if:

• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at 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 (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) 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).
• 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 for at least 28 days after the last 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.
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
• 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 for at least 28 days after the last dose of investigational product.
• 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: (1)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) level, or total bilirubin \> upper limit of normal (ULN); (2) For optional Cohort 3 only, AST or ALT greater or equal to 1.5 × ULN, provided that data from Cohorts 1 and 2 support this limit; (3) • 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 less than or equal to ULN plus ALT and AST are less than or equal to ULN plus alkaline phosphatase, hemoglobin, and reticulocyte count are all less than or equal to ULN.
• Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
• Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

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

ervogastat

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 27, 2017
• Study Start: March 16, 2017
• Primary Completion: July 13, 2017
• Study Completion: July 17, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)