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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01197781
First received: September 8, 2010
Last updated: November 19, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Drug Drug Interactions
Healthy Volunteers
Drug: FOSTAMATIN
Drug: Verapamil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1 Drug: FOSTAMATIN
Oral tablets - single dose
Experimental: Period 2 Drug: FOSTAMATIN
Oral tablets - single dose
Drug: Verapamil
Oral tablets - administered 3 times daily over 4 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197781

Locations
United States, Kansas
Recruiting Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD AstraZeneca
Principal Investigator: Carlos Prendes, MD Quintiles
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01197781     History of Changes
Other Study ID Numbers: D4300C00011
Study First Received: September 8, 2010
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
FosD
fostamatinib disodium
verapamil
healthy volunteers

Additional relevant MeSH terms:
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014