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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-04958242

Study type: Interventional

Funder types: Industry

Identifiers

NCT02228395

SAD-MAD (Other Identifier)

B1701016

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: PF-04958242

Drug: Placebo

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: PF-04958242

Drug: Placebo

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: PF-04958242

Drug: Placebo