Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03315494
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2017-10-06
Brief Title:
Safety Tolerability and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
A Phase 1 Double-Blind Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of Multiple Oral Doses of SKI-O-703 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
This double-blind placebo-controlled multiple ascending dose study is designed to evaluate the safety tolerability and pharmacokinetics PK of SKI-O-703 in healthy volunteers
Detailed Description:
This is a double-blind placebo-controlled study in healthy adult volunteers to evaluate the safety tolerability and pharmacokinetics PK of multiple ascending doses of SKI-O-703 A total of 24 subjects are planned to participate in 3 cohorts 8 subjects each In each cohort 6 subjects will be randomly assigned to receive SKI-O-703 and 2 subjects will be randomly assigned to matching placebo Dosing will be initiated with a 200 mg once daily QD dose cohort and escalated to 400 mg QD under fasting conditions for 7 days In the third cohort a 200 mg twice daily BID dose will be studied for 7 days Evening dosing will occur 12 hours after the morning dose and will be preceded by fasting for at least 3 hours After all 8 subjects in each cohort have received the study drug and been monitored the decision to escalate to the next dose cohort will be made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None