First-in-Human Study of PF-04958242 in Healthy Volunteers

NCT01159483 | Completed Phase 1

• 1 other identifier: B1701001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• Number of Participants Experiencing Adverse Events

  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.

  Baseline to Day 4

• 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

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

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.

Drug: PF-04958242; Drug: Placebo

Cohort B

EXPERIMENTAL

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).

Drug: PF-04958242; Drug: Placebo

Interventions

PF-04958242 DRUG

Administered as specified in the treatment arm

Cohort A; Cohort B

Placebo DRUG

Administered as specified in the treatment arm

Cohort A; Cohort B

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Singapore, 188770, Singapore

Location

MeSH Terms

Interventions

PF-04958242

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: July 15, 2010
• Primary Completion: October 16, 2010
• Study Completion: October 16, 2010
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

SG (1)