A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants

Biogen

Status and phase: Completed; Phase 1

Conditions: Systemic Lupos Erythematosus, SLE

Treatments: Drug: Placebo; Drug: BIIB068

Study type: Interventional

Funder types: Industry

Identifiers

NCT02829541

236HV101

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
• All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
• Must have a body mass index (BMI) between 18 and 32 kg/m2
• Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

• History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
• History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
• Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 6 patient groups

Cohorts 1

Experimental group

Description:

6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet

Treatment:

Drug: BIIB068

Drug: Placebo

Cohort 2

Experimental group

Description:

6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)

Treatment:

Drug: BIIB068

Drug: Placebo

Cohort 3

Experimental group

Description:

8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)

Treatment:

Drug: BIIB068

Drug: Placebo

Cohort 4

Experimental group

Description:

8 participants randomized (6:2) to receive a SAD administered orally in tablet

Treatment:

Drug: BIIB068

Drug: Placebo

Cohort 5

Experimental group

Description:

8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)

Treatment:

Drug: BIIB068

Drug: Placebo

Cohort 6

Experimental group

Description:

14 participants (all active) to receive a SAD administered orally in tablet(s)

Treatment:

Drug: BIIB068