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NCT01610388
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects
Phase 1 trial testing 500mg IV GSK1322322/placebo in Infections, Bacterial in 61 participants. Completed in 26 January 2012.
26 January 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | other |
| Enrollment | 61 |
| Start date | 13 September 2011 |
| Primary completion | 26 January 2012 |
| Estimated completion | 26 January 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 500mg IV GSK1322322/placebo
- 1000mg oral GSK1322322/placebo
- 1000mg IV GSK1322322/placebo — full drug profile →
- 1500mg oral GSK1322322/placebo dose — full drug profile →
- 1500mg IV GSK1322322/placebo — full drug profile →
- 2000mg IV GSK1322322J/placebo — full drug profile →
- 3000mg IV GSK1322322J/placebo — full drug profile →
- 1000mg IV GSK1322322J/placebo
Conditions studied
- Infections, Bacterial — all drugs for Infections, Bacterial →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 65, any sex, with Infections, Bacterial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This first time in human (FTIH) study will be the first administration of GSK1322322 as an intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute bioavailability of an oral tablet formulation as compared to the IV formulation.In addition, Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Penetration of GSK1322322 into epithelial lining fluid and alveolar macrophages as determined by bronchoalveolar lavage.
Naderer OJ, Rodvold KA, Jones LS, Zhu JZ, et al · · 2014 · cited 9× · PMID 24189245 · DOI 10.1128/aac.01836-13
Verify or expand the search:
- PubMed search for NCT01610388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06427317 — Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment · recruiting
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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 NCT01610388 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 GlaxoSmithKline
- Last refreshed: 12 June 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/NCT01610388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing