PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
NCT02831517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2017-03-09
Summary
The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
Conditions
- Healthy
- Trigeminal Neuralgia
Interventions
- DRUG
-
BIIB074
Administered as specified in the treatment arm
- DRUG
-
Matched Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- United Kingdom
Study Locations
More Related Trials
-
To Investigate Safety, Tolerability, and Pharmacokinetics of Treatment With BI 660848 Rising Single Doses (From 2 mg to 600 mg) Administered as Oral Drinking Solution (Powder in Bottle).
NCT01145014 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects
NCT05103878 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
NCT02071121 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
NCT05315947 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
NCT01587417 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants
NCT07225517 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
NCT01215773 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers
NCT02182414 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Itraconazole on the Pharmacokinetics of BIIB074
NCT02698267 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants
NCT05195008 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
NCT02259972 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
NCT03943056 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
NCT02443740 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers
NCT01841112 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Tolerability and Pharmacokinetic of BI 411034
NCT01581684 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
NCT02182297 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers
NCT02106247 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
NCT01843972 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers
NCT02194335 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
NCT02170740 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
NCT01587391 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults
NCT07141511 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects
NCT02170597 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation
NCT02283840 ·Status: COMPLETED ·Phase: PHASE1