camlipixant extended release (BLU-5937 extended release) / GSK - LARVOL DELTA

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Bellus Health Inc. - a GSK company | Recruiting ➔ Completed | N=32 ➔ 14

Enrollment change • Trial completion • Cough • Respiratory Diseases

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bellus Health Inc. - a GSK company | Active, not recruiting ➔ Recruiting

Enrollment open • Cough • Respiratory Diseases

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Bellus Health Inc. - a GSK company | Recruiting ➔ Active, not recruiting | N=16 ➔ 32 | Trial completion date: Mar 2023 ➔ May 2024 | Trial primary completion date: Feb 2023 ➔ May 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

BELLUS Health Announces Positive Results from its Phase 1 Bioavailability Equivalence Study Evaluating Once-Daily Extended-Release Formulation of Camlipixant in Comparison to Twice-Daily Immediate Release Formulation (Businesswire) - P1 | N=16 | NCT05570539 | Sponsor: Bellus Health Inc | "BELLUS Health Inc...announced positive data from its Phase 1 bioavailability equivalence study evaluating a once-daily Extended-Release ('ER') formulation of camlipixant in comparison to a twice-daily Immediate Release ('IR') formulation....The ER formulation demonstrated equivalent bioavailability to the IR formulation, with equivalent total systemic drug exposure (90% geometric mean AUC∞ and 82% geometric mean AUC24h), as well as equivalent minimum drug concentration (88% geometric mean C24h). The ER formulation was well tolerated, with the safety profile consistent with previous camlipixant trials and no taste-related adverse events reported."

P1 data • Chronic Cough • Cough • Respiratory Diseases

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Formulation (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Bellus Health Inc

New P1 trial