Evaluating the Safety, Tolerability, and Pharmacokinetics... | NCT03454126

NCT03454126

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2017-003982-90	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: BIIB095 5 mg	Experimental	Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 5 mg or placebo orally, followed by a fast of at least 4 hours post dose.	Drug: BIIB095 Drug: Placebo
Cohort 2: BIIB095 25 mg	Experimental	Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 25 mg or placebo orally, followed by a fast of at least 4 hours post dose.	Drug: BIIB095 Drug: Placebo
Cohort 3: BIIB095 100 mg	Experimental	Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 100 mg or placebo orally, followed by a fast of at least 4 hours post dose.	Drug: BIIB095 Drug: Placebo
Cohort 4 (Fasted): BIIB095 200 mg	Experimental	Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 200 mg or placebo orally, followed by a fast of at least 4 hours post dose.	Drug: BIIB095 Drug: Placebo
Cohort 4 (Fed): BIIB095 200 mg	Experimental

Name	Type	Description	Arm Group Labels	Other Names
BIIB095	Drug	Administered as specified in the treatment arm.	Cohort 10: BIIB095 300 mg BID Cohort 1: BIIB095 5 mg Cohort 2: BIIB095 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Serious Adverse Events (SAEs)	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; is a medically important event	Signing of Informed Consent (<=28 Days Prior to Day -1, Check-in) to End of Study (Up to 40 Days for Single-Ascending Dose (SAD) Cohorts 1-3 and 5-6; at Least 59 Days for SAD Cohort 4; Up to 53 Days for Multiple-Ascending Dose (MAD) Cohorts 7-10)
Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	Signing of Informed Consent (<=28 Days Prior to Day -1, Check-in) to End of Study (Up to 40 Days for Single-Ascending Dose (SAD) Cohorts 1-3 and 5-6; at Least 59 Days for SAD Cohort 4; Up to 53 Days for Multiple-Ascending Dose (MAD) Cohorts 7-10)
Percentage of Participants with Clinically Significant Abnormalities in Clinical Laboratory Assessments		Signing of Informed Consent (<=28 Days Prior to Day -1, Check-in) to End of Study (Up to 40 Days for Single-Ascending Dose (SAD) Cohorts 1-3 and 5-6; at Least 59 Days for SAD Cohort 4; Up to 53 Days for Multiple-Ascending Dose (MAD) Cohorts 7-10)
Percentage of Participants with Clinically Significant Abnormalities in Vital Signs		Signing of Informed Consent (<=28 Days Prior to Day -1, Check-in) to End of Study (Up to 40 Days for Single-Ascending Dose (SAD) Cohorts 1-3 and 5-6; at Least 59 Days for SAD Cohort 4; Up to 53 Days for Multiple-Ascending Dose (MAD) Cohorts 7-10)

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast)	Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.	Multiple Time-points on Days 1 through 4 for Single-Ascending Dose (SAD) Cohorts; Multiple Time-points on Days 1 through 15 for Multiple-Ascending Dose (MAD) Cohorts

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Ability of the subject 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 national and local subject privacy regulations.
Must have a body mass index between 18 and 30 kg/m2, inclusive.
All women of childbearing potential and all men must practice highly effective contraception during the study and for 5 times the half-life or 3 months, whichever is longer, after their last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 3 months after their last dose of study treatment.
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, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
Significant history of fainting or vaso-vagal attacks, as determined by the Investigator.
Current condition known to affect cardiac conduction, or a personal or familial history of Brugada syndrome.
Congenital nonhemolytic hyperbilirubinemia (Gilbert's syndrome).
History or risk of seizures or a history of epilepsy, significant head injury or related neurological disorders (excluding childhood febrile convulsions), as determined by the Investigator.
Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) prior to Day -1, or 5 half-lives of the agent, whichever is longer.
Exposure to more than 4 experimental chemical entities within 12 months prior to the first dosing day.
Breastfeeding, pregnant, or planning to become pregnant during study participation

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

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Leeds		LS2 9LH	United Kingdom
Hammersmith Medicines Research

ID	Term
D059350	Chronic Pain
D009437	Neuralgia

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms