NCT01539655

Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib

A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects When a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination With Omeprazole or Ranitidine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib

Detailed description

A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination with Omeprazole or Ranitidine

Conditions

• Medullary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	vandetanib	Oral tablets, 300 mg, single dose
DRUG	omeprazole	Oral capsules, 40 mg, multiple doses
DRUG	ranitidine	Oral tables, 150 mg, multiple doses

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-02-27
• Last updated: 2017-05-02

Locations

1 site across 1 country: United States