A Safety, Tolerability, Pharmacokinetic, and Pharmacodyna... | NCT03943056

NCT03943056

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Ascending Dose (SAD): Cohort 1A	Experimental	Participants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1.	Drug: BIIB091 Drug: Placebo
(SAD): Cohort 2A	Experimental	Participants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1.	Drug: BIIB091 Drug: Placebo
(SAD): Cohort 3A	Experimental	Participants will receive dose level 3 of BIIB091 or placebo, orally, while fasting on Day 1, then again following a 7 day washout and high-fat meal.	Drug: BIIB091 Drug: Placebo
(SAD): Cohort 4A	Experimental	Participants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1.	Drug: BIIB091 Drug: Placebo
(SAD): Cohort 5A	Experimental	Participants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1.	Drug: BIIB091 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BIIB091	Drug	Administered as specified in the treatment arm.	(MAD): Cohort 2B (MAD): Cohort 3B (SAD): Cohort 2A (SAD): Cohort 3A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.	Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)		Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations.
Have a body mass index between 18 and 30 kg/m2, inclusive.
All male participants must practice highly effective methods of contraception and not donate sperm during the study and for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
All female participants of childbearing potential must practice highly effective methods of contraception and not donate eggs during the study and for at least 90 days after their last dose of study treatment.
Must be in good health as by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

History of any clinically significant cardiac, endocrine, gastrointestinal, 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 of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Check-in).
Current enrollment or plan to enroll in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Check-in, or 5 half-lives of the drug or therapy, whichever is longer.
Breastfeeding, pregnant, or planning to become pregnant during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.