Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers

NCT ID: NCT02228395

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-22
• Study Completion Date: 2014-11-13

Brief Summary

This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers

Detailed Description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.

Group Type: EXPERIMENTAL

PF-04958242

Intervention Type: DRUG

Administered as specified in treatment arm

Placebo

Intervention Type: DRUG

Administered as specified in treatment arm

Cohort 2

Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.

Group Type: EXPERIMENTAL

PF-04958242

Intervention Type: DRUG

Administered as specified in treatment arm

Placebo

Intervention Type: DRUG

Administered as specified in treatment arm

Cohort 3

Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.

Group Type: EXPERIMENTAL

PF-04958242

Intervention Type: DRUG

Administered as specified in treatment arm

Placebo

Intervention Type: DRUG

Administered as specified in treatment arm

Interventions

PF-04958242

Administered as specified in treatment arm

Intervention Type: DRUG

Placebo

Administered as specified in treatment arm

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg

Exclusion Criteria

• 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).
• Other severe acute or chronic medical or psychiatric condition 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

SAD-MAD

Identifier Type: OTHER

Identifier Source: secondary_id

B1701016

Identifier Type: -

Identifier Source: org_study_id