Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)

NCT ID: NCT02443740

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-10-31

Brief Summary

This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects

Detailed Description

This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose-1 (Part A)

Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design

Group Type: EXPERIMENTAL

BIIB118

Intervention Type: DRUG

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo

Single Ascending Dose-2 (Part A)

Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design

Group Type: EXPERIMENTAL

BIIB118

Intervention Type: DRUG

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo

Single Dose Cerebrospinal Fluid (Part B)

Single maximum dose from Part A of BIIB118 administered to healthy volunteers to assess the PK of BIIB118 in CSF

Group Type: EXPERIMENTAL

BIIB118

Intervention Type: DRUG

Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension

Interventions

BIIB118

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo

Intervention Type: DRUG

BIIB118

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo

Intervention Type: DRUG

BIIB118

Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension

Intervention Type: DRUG

Other Intervention Names

PF-05251749; PF-05251749; PF-05251749

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female subjects of non-childbearing potential 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).

Female subjects of non-childbearing potential must meet at least one of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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).
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
• Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B8001001&StudyName=A%20Phase%201%2C%20Randomized%2C%20Double%20Blind%2C%20Placebo%20Controlled%20Study%20To%20Investigate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Relative%20Bioavailability%20Of%20Single%20Escalating%20Oral%20Doses%20Of%20Pf-05251749%20In%20Healthy%20Adult%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

SAD

Identifier Type: OTHER

Identifier Source: secondary_id

B8001001

Identifier Type: -

Identifier Source: org_study_id