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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIIB118

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443740

B8001001

SAD (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

32 participants in 3 patient groups

Single Ascending Dose-1 (Part A)

Experimental group

Description:

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

Treatment:

Drug: BIIB118

Drug: BIIB118

Drug: BIIB118

Single Ascending Dose-2 (Part A)

Experimental group

Description:

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

Treatment:

Drug: BIIB118

Drug: BIIB118

Drug: BIIB118

Single Dose Cerebrospinal Fluid (Part B)

Experimental group

Description:

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

Treatment:

Drug: BIIB118

Drug: BIIB118

Drug: BIIB118