Phase 1 Safety and PK Study of OLT1177 Capsules
|ClinicalTrials.gov Identifier: NCT02134964|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: OLT1177 Capsules Drug: Placebo Capsules||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: OLT1177 Capsules
A total of 5 patients in each cohort will receive OLT1177 Capsules:
Drug: OLT1177 Capsules
OLT1177 Capsules are an experimental drug.
Placebo Comparator: Placebo Capsules
A total of 1 patient in each cohort will receive Placebo Capsules:
Drug: Placebo Capsules
Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.
- Recording of adverse events [ Time Frame: Screening through Day 28 follow-up ]Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
- Safety Laboratory Measurements [ Time Frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit ]Blood samples will be drawn and analyzed for: chemistry, hematology, lipids and coagulation.
- Electrocardiogram [ Time Frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit ]Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.
- Vital Signs [ Time Frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit ]Vital signs (pulse, resting blood pressure, temperature and respirations) will be recorded and analyzed for changes throughout the duration of the study.
- Physical Examination [ Time Frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit ]Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134964
|United States, Texas|
|J&S Studies, Inc|
|College Station, Texas, United States, 77845|
|Principal Investigator:||Terry M Jones, MD, FAAD||J&S Studies|