Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 6:11 AM
Study NCT ID:
NCT03237832
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ARN-6039
Sponsor:
Arrien Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects.
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARN-6039
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: