Who is sponsoring NCT00680485?

NCT00680485 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00680485?

Interventions in NCT00680485: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg).

What condition does NCT00680485 study?

NCT00680485 studies Bacterial Infection, Infections, Bacterial.

Is NCT00680485 still recruiting?

NCT00680485 is currently terminated. Last updated 19 January 2017.

Last reviewed 2017-01-19 · How we verify

NCT00680485

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Three Part Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeat Escalating Oral Doses of GSK580416; the Safety, Tolerability, and Pharmacokinetics of GSK580416 Following a Loading Dose Regimen; and the Effect of Ketoconazole on the Pharmacokinetics of GSK580416

Terminated Phase 1 Last updated 19 January 2017

What this trial tests

Phase 1 trial testing GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg) in Bacterial Infection in 96 participants. Terminated before completion.

Timeline

1 June 2007

Primary endpoint
1 October 2007

1 October 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	1 June 2007
Primary completion	1 October 2007
Estimated completion	1 October 2007
Sites	1 location across Australia

Drugs / interventions tested

GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg) — full drug profile →

Conditions studied

Bacterial Infection — all drugs for Bacterial Infection →
Infections, Bacterial — all drugs for Infections, Bacterial →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 64, any sex, with Bacterial Infection or Infections, Bacterial. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety and tolerability of GSK580416 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests

Sponsor's own description

This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with ketoconazole, a PGP/CYP3A4 inhibitor.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Bacterial Infection

Currently open trials in the same condition.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT06709521 — Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) · Phase 4 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00680485 (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: 19 January 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/NCT00680485.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing