# A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects

> **NCT01818011** · PHASE1 · TERMINATED · sponsor: **GlaxoSmithKline** · enrollment: 12 (actual)

## Conditions studied

- Infections, Bacterial

## Interventions

- **DRUG:** GSK1322322 Initial fit for purpose tablets
- **DRUG:** GSK1322322 over granulated tablets
- **DRUG:** GSK1322322 intended commercial tablets
- **DRUG:** Placebo tablets
- **DRUG:** 13C-GSK1322322 stable isotope powder
- **DRUG:** GSK1322322 for injection
- **DRUG:** Placebo injection

## Key facts

- **NCT ID:** NCT01818011
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2013-08-07
- **Primary completion:** 2013-10-18
- **Final completion:** 2013-10-18
- **Target enrollment:** 12 (ACTUAL)
- **Why stopped:** Emerging GSK1322322 pre-clinical data ID'd potentially reactive metabolites previously not seen that changed the risk: benefit profile and led to a termination
- **Last updated:** 2019-01-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01818011

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01818011, "A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01818011. Licensed CC0.

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