Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
Phase 1
Completed
- Conditions
- Drug Drug InteractionsHealthy Volunteers
- Interventions
- Drug: FOSTAMATIN
- Registration Number
- NCT01197781
- Lead Sponsor
- AstraZeneca
- Brief Summary
This Study evaluates the possible drug interaction between FosD and verapamil when taken together.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Period 1 FOSTAMATIN - Period 2 FOSTAMATIN - Period 2 Verapamil -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Fostamatinib-Verapamil drug interactions via CYP3A4 or P-gp pathways?
How does R406 pharmacokinetics compare when administered alone versus with Verapamil in Phase 1 trials?
Are there biomarkers predicting CYP-mediated drug interactions between SYK inhibitors and calcium channel blockers?
What adverse event profiles emerge from combining Fostamatinib with P-gp inhibitors in healthy volunteers?
How do AstraZeneca's findings in NCT01197781 inform SYK inhibitor interactions with other CYP3A4 substrates?
Trial Locations
- Locations (1)
Recruiting Site
🇺🇸Overland Park, Kansas, United States
Recruiting Site🇺🇸Overland Park, Kansas, United States