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
Overview
- Phase
- Phase 1
- Intervention
- PF-04958242
- Conditions
- Healthy Volunteer
- Sponsor
- Biogen
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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 \[lbs\]);
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
Arms & Interventions
Cohort A
Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally. Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally.
Intervention: PF-04958242
Cohort A
Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally. Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally.
Intervention: Placebo
Cohort B
Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted). Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed).
Intervention: PF-04958242
Cohort B
Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted). Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed).
Intervention: Placebo
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 and at multiple time points up to Day 4
Number of Participants Experiencing Adverse Events
Time Frame: Baseline to Day 4
An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Time to Reach Cmax (Tmax)
Time Frame: Day 1 and at multiple time points up to Day 4
Apparent Terminal Elimination Half-life (t½)
Time Frame: Day 1 and at multiple time points up to Day 4
Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last)
Time Frame: Day 1 and at multiple time points up to Day 4
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
Time Frame: Day 1 and at multiple time points up to Day 4
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time Frame: Day 1 and at multiple time points up to Day 4
Apparent Total Plasma Clearance (CL/F)
Time Frame: Day 1 and at multiple time points up to Day 4