Trial record 1 of 1 for:
olt1177-04
Phase 1 Safety and PK Study of OLT1177 Capsules
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ClinicalTrials.gov Identifier: NCT02134964 |
Recruitment Status :
Completed
First Posted : May 9, 2014
Last Update Posted : March 6, 2015
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Sponsor:
Olatec Therapeutics LLC
Information provided by (Responsible Party):
Olatec Therapeutics LLC
Tracking Information | ||||
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First Submitted Date ICMJE | May 7, 2014 | |||
First Posted Date ICMJE | May 9, 2014 | |||
Last Update Posted Date | March 6, 2015 | |||
Study Start Date ICMJE | June 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase 1 Safety and PK Study of OLT1177 Capsules | |||
Official Title ICMJE | A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects | |||
Brief Summary | This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
35 | |||
Original Estimated Enrollment ICMJE |
36 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02134964 | |||
Other Study ID Numbers ICMJE | OLT1177-04 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Olatec Therapeutics LLC | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Olatec Therapeutics LLC | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Olatec Therapeutics LLC | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |