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Completed

NCT Number: NCT02829541

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

BIIB068

Drug

Administered as specified in the treatment arm.

Other names: Bruton's tyrosine kinase (BTK)

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 9 Days Post dose

  2. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: Up to 9 Days Post dose

  3. Number of participants with clinically significant Vital sign abnormalities

    Time frame: Up to 9 Days Post dose

  4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: Up to 9 Days Post dose

  5. Number of participants with clinically significant physical examination abnormalities

    Time frame: Up to 9 Days Post dose

Secondary outcomes

  1. PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)

    Time frame: Up to 48 Hours Post dose

  2. PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: Up to 48 Hours Post dose

  3. PK Assessment - Maximum observed concentration (Cmax)

    Time frame: Up to 48 Hours Post dose

  4. PK Assessment - Time to reach maximum observed concentration (Tmax)

    Time frame: Up to 48 Hours Post dose

  5. PK Assessment - Terminal elimination half-life (t1/2)

    Time frame: Up to 48 Hours Post dose

  6. PK Assessment - Apparent total body clearance (CL/F)

    Time frame: Up to 48 Hours Post dose

  7. PK Assessment - Apparent volume of distribution (Vz/F)

    Time frame: Up to 48 Hours Post dose

  8. PK Assessment - Amount of BIIB068 excreted in urine (Aeu)

    Time frame: Up to 48 Hours Post dose

  9. PK Assessment - Percentage (%fe) of BIIB068 excreted in urine

    Time frame: Up to 48 Hours Post dose

  10. PK Assessment - Renal clearance (CLr)

    Time frame: Up to 48 Hours Post dose

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB068, a Bruton's Tyrosine Kinase Inhibitor, in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2016
Registry last updated
Mar 15, 2017

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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