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Completed

NCT Number: NCT01159483

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Singapore, 188770

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04958242

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 and at multiple time points up to Day 4

  3. Time to Reach Cmax (Tmax)

    Time frame: Day 1 and at multiple time points up to Day 4

  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

  5. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

    Time frame: Day 1 and at multiple time points up to Day 4

  6. Apparent Total Plasma Clearance (CL/F)

    Time frame: Day 1 and at multiple time points up to Day 4

  7. Apparent Terminal Elimination Half-life (t½)

    Time frame: Day 1 and at multiple time points up to Day 4

  8. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2010
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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