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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 02, 2014