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Completed

NCT Number: NCT02521545

Single-Dose Study of a New Formulation of BIIB061

The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females.
  • All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
  • Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
  • Body mass index of 18.0 to 30.0 kg/m2, inclusive.

Key Exclusion Criteria:

  • History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • Prior exposure to BIIB061.
  • History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
  • Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
  • Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
  • Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
  • Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
  • Blood donation within 30 days prior to the study
  • Surgery within 3 months prior to the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BIIB061

Drug

Capsule

Primary outcomes

  1. PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: Day 1-4, 6, 10, 14, 21

  2. PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)

    Time frame: Day 1-4, 6, 10, 14, 21

  3. PK parameter - maximum observed concentration (Cmax)

    Time frame: Day 1-4, 6, 10, 14, 21

Secondary outcomes

  1. PK parameter - Time to reach maximum observed concentration (Tmax)

    Time frame: Day 1-4, 6, 10, 14, 21

  2. PK parameter - half-life (t1/2)

    Time frame: Day 1-4, 6, 10, 14, 21

  3. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 21 days

  4. Assessment of changes from baseline in Clinical laboratory parameters

    Time frame: Up to 21 days

  5. Assessment of clinically relevant abnormalities in Vital signs

    Time frame: Up to 21 days

  6. Assessment of physical examinations

    Time frame: Up to 21 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Sep 7, 2015

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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