Phase 1 Safety and PK Study of OLT1177 Capsules
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|