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NCT03198624: HTL0018318
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
Phase 1 trial testing HTL0018318 in Safety Issues in 54 participants. Completed in 20 August 2017.
20 August 2017
Quick facts
| Lead sponsor | Nxera Pharma UK Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 16 May 2017 |
| Primary completion | 20 August 2017 |
| Estimated completion | 20 August 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- HTL0018318 — full drug profile →
- Placebo oral capsule
Conditions studied
- Safety Issues — all drugs for Safety Issues →
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Nxera Pharma UK Limited — full company profile →
Who can join
Adults 20 to 40, male only, with Safety Issues or Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03198624
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HTL0018318
Trials testing the same drug.
- NCT03456349 — Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care · Phase 1 · completed
Other recruiting trials for Safety Issues
Currently open trials in the same condition.
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- NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
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- NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · recruiting
Other Nxera Pharma UK Limited trials
Trials by the same sponsor.
- NCT04935320 — Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution · Phase 1 · completed
- NCT04941989 — A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562 · Phase 1 · terminated
- NCT04462263 — Study to Investigate the Receptor Occupancy of HTL0014242 Using [18F] FPEB in Healthy Male Subjects · Phase 1 · completed
- NCT03847207 — A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310 · Phase 1 · completed
- NCT03785054 — Phase 1, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of mGlu5 NAM HTL0014242 · Phase 1 · completed
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 NCT03198624 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nxera Pharma UK Limited
- Last refreshed: 7 September 2017
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/NCT03198624.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing