Phase 1
N=9
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02228395 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-04958242 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
4; 4; 2; 4; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern |
1; 2; 1; 3 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Signs Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings |
0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
3.119; 5.602; 6.193 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.29; 1.80; 1.50 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
42.79; 76.00; 88.27 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) |
45.34; 79.34; 90.78 | — |
| SECONDARY Apparent Clearance (CL/F) |
128.6; 126.0; 146.9 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
367.9; 327.0; 337.2 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) |
37.33; 34.10; 29.07 | — |
| SECONDARY Dose Normalized Cmax (Cmax[dn]) |
8.923; 9.331; 7.745 | — |
| SECONDARY Dose Normalized AUClast (AUClast[dn]) |
122.4; 126.6; 110.5 | — |
| SECONDARY Dose Normalized AUCinf (AUCinf[dn]) |
129.7; 132.3; 113.6 | — |
Summary
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02228395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.