Who is sponsoring NCT01682408?

NCT01682408 is sponsored by AstraZeneca.

What drugs are being tested in NCT01682408?

Interventions in NCT01682408: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed, Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A), Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B), Ranitidine.

What condition does NCT01682408 study?

NCT01682408 studies Pharmacokinetics.

Is NCT01682408 still recruiting?

NCT01682408 is currently completed. Last updated 27 December 2012.

Last reviewed 2012-12-27 · How we verify

NCT01682408: PK Combination

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

An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone in Fed and Fasted State and in Combination With Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Completed Phase 1 Last updated 27 December 2012

What this trial tests

Phase 1 trial testing Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) in Pharmacokinetics in 28 participants. Completed in 1 December 2012.

Timeline

1 September 2012

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Masking	none
Primary purpose	basic science
Enrollment	28
Start date	1 September 2012
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	1 location across United States

Drugs / interventions tested

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) — full drug profile →
Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed — full drug profile →
Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) — full drug profile →
Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) — full drug profile →
Ranitidine (ranitidine) — full drug profile →

Conditions studied

Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Pharmacokinetics. Healthy volunteers can join.

What's being measured

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

Pharmacokinetics profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
Time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

Sponsor's own description

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Trials by the same sponsor.

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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 NCT01682408 (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 AstraZeneca
Last refreshed: 27 December 2012

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/NCT01682408.

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