Last updated: 11/06/2018 23:57:14
A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single, Oral Doses of the Thrombopoietin Receptor Agonist, ELTROMBOPAG; and the Effect of ELTROMBOPAG™ on Cardiac Conduction as Compared to Placebo and Single Oral Doses of Moxifloxacin in Healthy Adult Subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single, Oral Doses of the Thrombopoietin Receptor Agonist, ELTROMBOPAG; and the Effect of ELTROMBOPAG™ on Cardiac Conduction as Compared to Placebo and Single Oral Doses of Moxifloxacin in Healthy Adult Subjects
Trial description: A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single, Oral Doses of the Thrombopoietin Receptor Agonist, ELTROMBOPAG; and the Effect of ELTROMBOPAG™ on Cardiac Conduction as Compared to Placebo and Single Oral Doses of Moxifloxacin in Healthy Adult Subjects
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Anand SP, Murray SC, Koch GC. A multivariate approach to sample size calculations for thorough QT studies. J Biopharm Stat.
Matthys G, Park JW, McGuire S, Wire MB, Bowen C, Williams D, Jenkins J, Peng B. Clinical Pharmacokinetics, Platelet Response, and Safety of Eltrombopag at Supratherapeutic Doses of up to 200 mg Once Daily in Healthy Volunteers . J Clin Pharmacol. 2010;doi(10):
Matthys G, Park JW, McGuire S, Wire MB, Zhangl J, Bowen C, Williams D, Jenkins JM, Peng B. Eltrombopag does not affect cardiac repolarisation: results from a definitive QTc study in healthy subjects. British Journal of Clinical Pharmacology. 2010;70(1):24-33.
Medical condition
Purpura, Thrombocytopenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
March 2006 to July 2007
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-27-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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