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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupos Erythematosus, SLE
• Intervention / Treatment: Drug: Placebo; Drug: BIIB068

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohorts 1; 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)
Experimental: Cohort 2; 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)
Experimental: Cohort 3; 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)
Experimental: Cohort 4; 8 participants randomized (6:2) to receive a SAD administered orally in tablet	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)
Experimental: Cohort 5; 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)
Experimental: Cohort 6; 14 participants (all active) to receive a SAD administered orally in tablet(s)	Drug: BIIB068; Administered as specified in the treatment arm.; Other Names: Bruton's tyrosine kinase (BTK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
PK Assessment - Apparent total body clearance (CL/F)	Up to 48 Hours Post dose
PK Assessment - Apparent volume of distribution (Vz/F)	Up to 48 Hours Post dose
PK Assessment - Amount of BIIB068 excreted in urine (Aeu)	Up to 48 Hours Post dose
PK Assessment - Percentage (%fe) of BIIB068 excreted in urine	Up to 48 Hours Post dose
PK Assessment - Renal clearance (CLr)	Up to 48 Hours Post dose

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Single Ascending Dose (SAD), Healthy Volunteers
• Other Study ID Numbers: 236HV101