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NCT02134964
A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
Phase 1 trial testing OLT1177 Capsules in Healthy Volunteers in 35 participants. Completed in 1 December 2014.
1 December 2014
Quick facts
| Lead sponsor | Olatec Therapeutics LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 35 |
| Start date | 1 June 2014 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- OLT1177 Capsules — full drug profile →
- Placebo Capsules — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Olatec Therapeutics LLC — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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The role of inflammasomes in human diseases and their potential as therapeutic targets.
Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y -
Targeting pyroptosis in inflammatory bowel disease: A potentially effective therapeutic approach.
Dong WW, Liu T, He LX, He WT. · · 2025 · cited 1× · PMID 41358180 · DOI 10.3748/wjg.v31.i43.111358 -
The NLRP3 Inflammasome: Mechanisms of Activation, Regulation, and Therapeutic Opportunities.
Zou C, Jiang S, Li H, Zhao K, et al · · 2026 · PMID 41799937 · DOI 10.1002/mco2.70660
Verify or expand the search:
- PubMed search for NCT02134964
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Olatec Therapeutics LLC trials
Trials by the same sponsor.
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- NCT03534297 — Study of Dapansutrile Capsules in Heart Failure · Phase 1 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02134964 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Olatec Therapeutics LLC
- Last refreshed: 5 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02134964.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing