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Completed

NCT Number: NCT03454126

Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants

The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Leeds, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB095

Drug

Administered as specified in the treatment arm.

Placebo

Drug

Administered as specified in the treatment arm.

Primary outcomes

  1. Percentage of Participants with Serious Adverse Events (SAEs)

    Time frame: 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)

    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

  2. Percentage of Participants with Adverse Events (AEs)

    Time frame: 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)

    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.

  3. Percentage of Participants with Clinically Significant Abnormalities in Clinical Laboratory Assessments

    Time frame: 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)

  4. Percentage of Participants with Clinically Significant Abnormalities in Vital Signs

    Time frame: 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)

  5. Percentage of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: 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)

  6. Percentage of Participants with Clinically Significant Abnormalities in Physical Examinations

    Time frame: 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

  1. Area Under the Concentration-Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  2. AUC from Time Zero Extrapolated to Infinity (AUC∞)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  3. AUC Within a Dosing Interval (AUCtau)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  4. Maximum Observed Concentration (Cmax)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  5. Trough Concentration (Ctrough)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  6. Time to Cmax (Tmax)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  7. Terminal Elimination Half-Life (t1/2)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  8. Apparent Total Body Clearance (CL/F)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  9. Apparent Volume of Distribution (Vz/F)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  10. Accumulation Ratio (AR)

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  11. Amount (Aeu) Excreted in Urine

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

  12. Percentage (%fe) Excreted in Urine

    Time frame: 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

    Pharmacokinetic (PK) parameter calculated to assess the PK of BIIB095 in blood.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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