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NCT01072162
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect
Phase 1 trial testing Eltrombopag in Purpura, Thrombocytopaenic, Idiopathic in 40 participants. Completed in 7 April 2010.
7 April 2010
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 12 January 2010 |
| Primary completion | 7 April 2010 |
| Estimated completion | 7 April 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Eltrombopag (ELTROMBOPAG) — full drug profile →
- Eltrombopag (ELTROMBOPAG) — full drug profile →
Conditions studied
- Purpura, Thrombocytopaenic, Idiopathic — all drugs for Purpura, Thrombocytopaenic, Idiopathic →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 64, any sex, with Purpura, Thrombocytopaenic, Idiopathic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit. During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation.
Desborough M, Estcourt LJ, Doree C, Trivella M, et al · · 2016 · cited 10× · PMID 27548292 · DOI 10.1002/14651858.cd010982.pub2
Verify or expand the search:
- PubMed search for NCT01072162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eltrombopag
Trials testing the same drug.
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- NCT07113743 — Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease · Phase 1, PHASE2 · enrolling by invitation
- NCT07093606 — Eltrombopag Induced Liver Dysfunction During Treatment of Immunethrombocytopenic Purpura · NA · recruiting
- NCT06345495 — High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly · Phase 2 · recruiting
- NCT05653219 — A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia · Phase 3 · active not recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
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- 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 NCT01072162 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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: 14 November 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/NCT01072162.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing