Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Elderly Subjects; Healthy Adult Subjects

Treatments: Drug: Melatonin; Drug: BIIB118

Study type: Interventional

Funder types: Industry

Identifiers

NCT02691702

MAD (Other Identifier)

B8001002

Details and patient eligibility

About

This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118

Full description

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

Enrollment: 97 patients

Sex: All

Ages: 18 to 85 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 (Parts A and B) or 65 and 85 years (Part C), 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: Parallel Assignment

Masking: Double Blind

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97 participants in 3 patient groups

Multiple Doses - Part A

Experimental group

Description:

Multiple ascending doses administered in the morning to healthy adult subjects in a parallel study design

Treatment:

Drug: BIIB118

Drug: Melatonin

Multiple Dose - Part B

Experimental group

Description:

Multiple ascending doses administered in the evening to healthy adult subjects in a parallel study design

Treatment:

Drug: BIIB118

Multiple Doses - Elderly

Experimental group

Description:

Multiple ascending doses administered to elderly subjects

Treatment:

Drug: BIIB118