A Single Dose Study Of PF-06678552 In Healthy Subjects

NCT01992614 | Completed Phase 1

• 1 other identifier: B7611001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.

Conditions

Healthy

Keywords

Single Ascending Dose; healthy subjects; Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

  0 to 72 hours post dose

Secondary Outcomes (15)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552

  0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552

  0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

• Maximum Observed Plasma Concentration (Cmax) for for PF-06678552

  0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552

  0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

• Plasma Decay Half-Life (t1/2) for PF-06678552

  0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Study Arms (3)

Cohort 1

EXPERIMENTAL

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Drug: PF-06678552 or Placebo

Cohort 2

EXPERIMENTAL

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Drug: PF-06678552 or Placebo

Cohort 3

EXPERIMENTAL

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Drug: PF-06678552 or Placebo

Interventions

PF-06678552 or Placebo DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

Cohort 1

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 18 to 30.5 kg/m2; and a total body weight \>50 kg
• Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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 Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Condition Hierarchy (Ancestors)

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

BE (1)