Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

Biogen

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: PF-04958242

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238679

B1701002

Details and patient eligibility

About

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

Full description

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

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

Enrollment: 20 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
• Total body weight >50 kilograms (kg) (110 pounds [lbs]);

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);
• Positive urine drug screen;
• Pregnant or nursing females, and females of child bearing potential;
• 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 participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 7 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.

Treatment:

Drug: PF-04958242

Cohort 2

Experimental group

Description:

Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.

Treatment:

Drug: PF-04958242

Cohort 3

Experimental group

Description:

Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.

Treatment:

Drug: PF-04958242

Cohort 4

Experimental group

Description:

Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.

Treatment:

Drug: PF-04958242

Cohort 5

Experimental group

Description:

Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.

Treatment:

Drug: PF-04958242

Cohort 6

Experimental group

Description:

Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.

Treatment:

Drug: PF-04958242

Matching Placebo

Placebo Comparator group

Description:

Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.

Treatment:

Drug: Placebo