Clinical trial NCT01159483: First-in-Human Study of PF-04958242 in Healthy Volunteers
Official title: A Phase I, First-in-Human, Randomized, Subject and Investigator-Blind, Sponsor Open, Single Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pf-04958242 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242 administered orally to healthy adult participants.

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

Eligibility 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

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Baseline to Day 4
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Time to Reach Cmax (Tmax)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Apparent Total Plasma Clearance (CL/F)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Apparent Terminal Elimination Half-life (t½)
timeFrame: Day 1 and at multiple time points up to Day 4
measure: Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last)
timeFrame: Day 1 and at multiple time points up to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: