Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT03237832
Brief Summary:
This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy subjects.
Detailed Description:
To determine the safety and tolerability in healthy subjects, ARN-6039 will be dosed in a single-center, randomized, double-blind, placebo-controlled, ascending dose study. Five cohorts of 10 subjects will be dosed in ascending order, beginning with a single dose of 50 mg of ARN-6039. Subsequent cohorts will be administered single doses of 100 mg, 150 mg, 200 mg, or 300 mg. Safety, tolerability, and pharmacokinetics will be evaluated prior to each dose escalation using the assessment of all available safety and pharmacokinetic data.
In Cohorts 1 through 4, subjects will receive a single dose of ARN-6039 or matching placebo under fasted conditions. In Cohort 5, subjects will be administered a single dose of ARN-6039 or a single dose of matching placebo under fasted conditions in Period 1 and under fed conditions in Period 2 with a minimum 5-day washout period between each dose.
To support the administration of ARN-6039 in humans, preclinical toxicology studies performed in rats and dogs demonstrated tolerability exceeding the intended therapeutic dose. In addition, the safety and efficacy of ARN-6039 has been demonstrated in model systems and is anticipated to be well tolerated in humans. This study will be the first administration of ARN-6039 in human subjects.
Study:
NCT03237832
Study Brief:
Protocol Section:
NCT03237832