Last reviewed · How we verify
NCT00488098
An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
Phase 1 trial testing GSK372475 in Healthy Subjects in 66 participants. Completed.
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 1 July 2007 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- GSK372475 — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
- Depressive Disorder — all drugs for Depressive Disorder →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy Subjects or Depressive Disorder. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Time frame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Sponsor's own description
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
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 NCT00488098
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK372475
Trials testing the same drug.
- NCT00728208 — GSK372475 PK Study in Healthy Volunteers · Phase 1 · completed
- NCT00420641 — MDD POC Study GSK372475 Subjects Depressive Disease · Phase 2 · completed
Other recruiting trials for Healthy Subjects
Currently open trials in the same condition.
- NCT07222020 — Phase 1 Study of Intravaginal KB15A · Phase 1 · recruiting
- NCT07350538 — The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL · NA · active not recruiting
- NCT07304791 — This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and P · Phase 1 · recruiting
- NCT07059858 — Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities · recruiting
- NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
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 NCT00488098 (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 GlaxoSmithKline
- Last refreshed: 31 May 2012
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/NCT00488098.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing