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

NCT02829541 | Completed Phase 1

• 1 other identifier: 236HV101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupos Erythematosus, SLE

Keywords

Single Ascending Dose (SAD), Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

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

  Up to 9 Days Post dose

• Number of participants with clinically significant laboratory assessment abnormalities

  Up to 9 Days Post dose

• Number of participants with clinically significant Vital sign abnormalities

  Up to 9 Days Post dose

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

  Up to 9 Days Post dose

• Number of participants with clinically significant physical examination abnormalities

  Up to 9 Days Post dose

Secondary Outcomes (10)

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

  Up to 48 Hours Post dose

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

  Up to 48 Hours Post dose

• PK Assessment - Maximum observed concentration (Cmax)

  Up to 48 Hours Post dose

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

  Up to 48 Hours Post dose

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

  Up to 48 Hours Post dose

Study Arms (6)

Cohorts 1

EXPERIMENTAL

6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet

Drug: BIIB068; Drug: Placebo

Cohort 2

EXPERIMENTAL

6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)

Drug: BIIB068; Drug: Placebo

Cohort 3

EXPERIMENTAL

8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)

Drug: BIIB068; Drug: Placebo

Cohort 4

EXPERIMENTAL

8 participants randomized (6:2) to receive a SAD administered orally in tablet

Drug: BIIB068; Drug: Placebo

Cohort 5

EXPERIMENTAL

8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)

Drug: BIIB068; Drug: Placebo

Cohort 6

EXPERIMENTAL

14 participants (all active) to receive a SAD administered orally in tablet(s)

Drug: BIIB068

Interventions

BIIB068 DRUG

Administered as specified in the treatment arm.

Also known as: Bruton's tyrosine kinase (BTK)

Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohorts 1

Placebo DRUG

Administered as specified in the treatment arm

Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohorts 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Agammaglobulinaemia Tyrosine Kinase

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)