CLINICAL TRIALS PROFILE FOR BIIB091
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Clinical Trials for BIIB091
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03943056 ↗ | A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants | Completed | Biogen | Phase 1 | This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK). |
| NCT04564612 ↗ | Study of BIIB091 Formulations in Healthy Participants | Recruiting | Biogen | Phase 1 | The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to evaluate the PK profile of the BIIB091 immediate release (IR) tablet formulation in healthy participants after single dose administration (Part 1B); to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a proton pump inhibitor (PPI) compared to healthy participants not taking a PPI, to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a cytochrome P450 (CYP)3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor (Part 2); to evaluate the PK of the selected BIIB091 regimen in healthy participants after multiple dose administration (Part 3). The secondary objectives of this study are: to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule (DiC) reference formulation in healthy participants in the fasted state, to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state (Part 1); to determine the PK of a single dose of the BIIB091 IR tablet formulation in the fed and fasted state in healthy participants, to evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after administration of divided total daily doses over a 24 hour period in the fasted or fed state, to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR tablet formulation compared to that of the IR DiC reference formulation in healthy participants in the fasted state, to determine the PK of a single or divided dose of the BIIB091 IR tablet formulation administered with an alternative meal composition in healthy participants, to assess the safety and tolerability of a single or divided dose of BIIB091 when administered as the IR tablet formulation and IR DiC reference formulation in healthy participants in fed or fasted state (Part 1B); to confirm the PK profiles of the selected BIIB091 regimen in healthy participants after single dose administration, and to establish a reference exposure for the assessment of drug interaction, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a PPI, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a CYP3A4 inhibitor (Part 2); to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants (Part 3). |
| NCT05798520 ↗ | A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis | Not yet recruiting | Biogen | Phase 2 | The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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