CompletedPhase 1

Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers

United States12 participantsStarted 2014-09-22

Plain-language summary

This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline

Timeframe: Baseline up to Day 10

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Baseline up to 28 days after last study drug administration.

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

Timeframe: Baseline up to Day 10

Number of Participants With Potentially Clinically Significant Vital Signs Findings

Timeframe: Baseline up to Day 10

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Timeframe: Baseline up to Day 10

Number of Participants With Abnormal Physical Examination Findings

Timeframe: Baseline up to Day 10

Number of Participants With Abnormal Neurological Examination Findings

Trial details

NCT IDNCT02228395

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11-13

Results submitted2015-11-12

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline

Timeframe: Baseline up to Day 10

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Baseline up to 28 days after last study drug administration.

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

Timeframe: Baseline up to Day 10

Number of Participants With Potentially Clinically Significant Vital Signs Findings

Timeframe: Baseline up to Day 10

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Timeframe: Baseline up to Day 10

Number of Participants With Abnormal Physical Examination Findings

Timeframe: Baseline up to Day 10

Number of Participants With Abnormal Neurological Examination Findings