Healthy Volunteer
Conditions
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.
Interventions
DRUGPF-04958242
Administered as specified in the treatment arm
DRUGPlacebo
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 and at multiple time points up to Day 4 | — |
| Time to Reach Cmax (Tmax) | 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) | Day 1 and at multiple time points up to Day 4 | — |
| Number of Participants Experiencing Adverse Events | 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. |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Day 1 and at multiple time points up to Day 4 | — |
| Apparent Total Plasma Clearance (CL/F) | Day 1 and at multiple time points up to Day 4 | — |
| Apparent Terminal Elimination Half-life (t½) | 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) | Day 1 and at multiple time points up to Day 4 | — |
Countries
Singapore
Outcome results
None listed