A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects

NCT03230383 | Completed Phase 1 FDA Drug

• 2 other identifiers: C25410022017-001649-28
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort. For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events (AEs)

  Number of participants with reported adverse events

  Baseline 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 24 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 24 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 24 days after last dose of study medication

Secondary Outcomes (7)

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

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14

• AUCtau for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14

• Time to Reach Maximum Observed Concentration for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14

• Dose normalized Cmax for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14

• Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14

Study Arms (7)

Cohort 1_90mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 2_300mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 3_900mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 4_1800mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Cohort 5_3000mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Optional Cohort 6_TBD mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Optional Cohort 7_TBD mg and Matching Placebo

EXPERIMENTAL

Drug: PF-06865571; Drug: Placebo

Interventions

PF-06865571 DRUG

Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.

Cohort 1_90mg and Matching Placebo

Placebo DRUG

Matching Placebo for PF-06865571 for each cohort.

Cohort 1_90mg and Matching Placebo; Cohort 2_300mg and Matching Placebo; Cohort 3_900mg and Matching Placebo; Cohort 4_1800mg and Matching Placebo; Cohort 5_3000mg and Matching Placebo; Optional Cohort 6_TBD mg and Matching Placebo; Optional Cohort 7_TBD mg 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 greater than 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);
• Subjects with fasting LDL-C level \>190 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
• Subjects with fasting TG level \>400 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
• 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).
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
• Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; 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.
• Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
• 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 (2)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

• Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.

  PMID: 36690550 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (1)