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Completed

NCT Number: NCT01197781

Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers

This Study evaluates the possible drug interaction between FosD and verapamil when taken together.

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Key information

Conditions

Drug Drug Interactions Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Recruiting Site

Overland Park, Kansas, United States

About this study

An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
  • Females must be of non-childbearing potential

Exclusion criteria

  • History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
  • Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
  • Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
  • Current smokers or use of nicotine products within 1 month prior to enrollment

Treatment and study plan

FOSTAMATIN

Drug

Oral tablets - single dose

Verapamil

Drug

Oral tablets - administered 3 times daily over 4 days

Primary outcomes

  1. To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.

    Time frame: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD

Secondary outcomes

  1. To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.

    Time frame: Screening, throughout both treatment periods, and follow-up.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2010
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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