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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197781
• Other study ID #: D4300C00011
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2010
• Last updated: November 19, 2010
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Drug Drug Interactions
• Healthy Volunteers

Intervention

Drug:
• FOSTAMATIN
Oral tablets - single dose
• Verapamil
Oral tablets - administered 3 times daily over 4 days

Locations

Country	Name	City	State
United States	Recruiting Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD	No
Secondary	To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.		Screening, throughout both treatment periods, and follow-up.	Yes