A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

NCT02391623 | Completed Phase 1

• 2 other identifiers: B78710022015-000130-29
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.

Conditions

Healthy Subjects

Keywords

Multiple Ascending Dose; Healthy Subjects; Hyperlipidemia; Lipid Metabolism Disorders; Metabolic Diseases

Outcome Measures

Primary Outcomes (4)

• Assessment of adverse events (AEs).

  0-25 days

• Assessment of clinical laboratory tests.

  0-25 days

• Assessment of vital signs (including blood pressure and pulse rate).

  0-25 days

• Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

  0-25 days

Secondary Outcomes (20)

• Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

  0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

• Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

  0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

• Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14

  0, 1, 2, 3, 4, 6, 8, 12 hours post dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

  0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

  0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Study Arms (6)

Cohort 1

EXPERIMENTAL

Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Cohort 2

EXPERIMENTAL

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Cohort 3

EXPERIMENTAL

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Cohort 4

EXPERIMENTAL

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Cohort 5

EXPERIMENTAL

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Cohort 6

EXPERIMENTAL

Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Drug: PF-06427878; Drug: Placebo

Interventions

PF-06427878 DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female subjects of non childbearing potential.
• Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight \>50 kg
• Subjects with fasting TG level of \>=90 mg/dL and \<=500 mg/dL following an overnight fast
• Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

• Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701.

  PMID: 31776293 DERIVED

Related Links

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

MeSH Terms

Conditions

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Condition Hierarchy (Ancestors)

Dyslipidemias; Nutritional and Metabolic Diseases

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

BE (1)