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lumacaftor q12h+ ivacaftor q12h · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Approximately 12 subjects (male and female) with moderate hepatic impairment |
| Group B | EXPERIMENTAL | Approximately 12 healthy subjects (male and female) |
| Name | Type | Description |
|---|---|---|
| lumacaftor 200 mg q12h + ivacaftor 250 mg q12h | DRUG | - |
Inclusion Criteria: Group A: Subjects with Moderate Hepatic Impairment * Male and female 18 to 65 years of age (inclusive) * Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit * Willing and able to comply w...
Lumacaftor q12h + ivacaftor q12h is a combination of two small molecule drugs developed by Vertex Pharmaceuticals Incorporated (VRTX). It pairs lumacaftor 200 mg every 12 hours with ivacaftor 250 mg every 12 hours. The combination has been studied in a Phase 1 clinical trial in people with moderate hepatic impairment and in healthy subjects.
Lumacaftor q12h + ivacaftor q12h targets CFTR, the cystic fibrosis transmembrane conductance regulator. Lumacaftor is a CFTR stabiliser, and the combination is designed to act on this protein target. Both components are small molecules, and the regimen is dosed every 12 hours.
Vertex Pharmaceuticals Incorporated, which trades under the ticker VRTX, is the developer of lumacaftor q12h + ivacaftor q12h. The company is responsible for the development of this small molecule combination of lumacaftor 200 mg q12h and ivacaftor 250 mg q12h.
Lumacaftor q12h + ivacaftor q12h is in Phase 1 development. The program has one completed Phase 1 trial, and no active trials are ongoing. It is an investigational combination and is not approved for any indication based on the available development information.
Lumacaftor q12h + ivacaftor q12h has been evaluated in one completed Phase 1 trial, NCT01888393, titled Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects. That trial enrolled 23 participants across Czechia and Slovakia and included healthy volunteers aged 18 years and older.