MedDataX Logo

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

NCT ID: NCT01159483

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-15

Study Completion Date

2010-10-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

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).

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04958242

Administered as specified in the treatment arm

Intervention Type DRUG

Placebo

Administered as specified in the treatment arm

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1701001

Identifier Type: -

Identifier Source: org_study_id