Clinical trial · Interventional
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
NCT01539655CI-TRIAL-00027310VandetanibcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medullary Thyroid Cancer | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omeprazole | Drug | — | UNRESOLVED |
| ranitidine | Drug | — | UNRESOLVED |
| vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- vandetanib then vandetanib + omeprazole
- description
- Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2
- interventionNames
- Drug: vandetanib
- Drug: omeprazole
- type
- EXPERIMENTAL
- label
- vandetanib + omeprazole then vandetanib
- description
- Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2
- interventionNames
- Drug: vandetanib
- Drug: omeprazole
- type
- EXPERIMENTAL
- label
- vandetanib then vandetanib + ranitidine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures * Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 * Inclusive Females must have a negative pregnancy test at screening and on admission to the study center * Females must not be lactating and must be of non childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization. Exclusion Criteria: * History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease. * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity * Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center * Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion * Clinically significant abnormal12-lead ECG as assessed by the Investigator * QTcF interval greater than 450 ms Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody * Human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
References
Publications (1)
- DERIVEDJohansson S, Read J, Oliver S, Steinberg M, Li Y, Lisbon E, Mathews D, Leese PT, Martin P. Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine. Clin Pharmacokinet. 2014 Sep;53(9):837-47. doi: 10.1007/s40262-014-0161-2. PMID 25117183