Medullary Thyroid CancerPhase 1VandetanibNCT01539655
Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib
A Phase 1 study testing vandetanib, omeprazole and ranitidine in people with Medullary Thyroid Cancer, run by Sanofi at 1 site in United States.
Trial summary
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- vandetanib, omeprazole and ranitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
Read the 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
- Being tested
- vandetanib, omeprazole, ranitidine
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, vandetanib, omeprazole, ranitidine
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vandetanibDrug
Oral tablets, 300 mg, single dose
omeprazoleDrug
Oral capsules, 40 mg, multiple doses
ranitidineDrug
Oral tables, 150 mg, multiple doses
| Study group | Role | What they receive |
|---|---|---|
| vandetanib then vandetanib + omeprazole | Experimental | Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 Receives: Drug: vandetanib; Drug: omeprazole |
| vandetanib + omeprazole then vandetanib | Experimental | Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 Receives: Drug: vandetanib; Drug: omeprazole |
| vandetanib then vandetanib + ranitidine | Experimental | Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2 Receives: Drug: vandetanib; Drug: ranitidine |
| vandetanib + ranitidine then vandetanib | Experimental | Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 Receives: Drug: vandetanib; Drug: ranitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Secondary outcomes (6)
Frequency and severity of adverse events
Measured: Treatment period + 7-14 days
ECG data
Measured: Treatment period + 7-14 days
Laboratory data
Measured: Treatment period + 7-14 days
Vital signs data
Measured: Treatment period + 7-14 days
Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539655
- Sponsor's protocol ID
- D4200C00101
- Acronym
- Vandetanib
- Status last verified
- Apr 2017
- First submitted
- 10 Feb 2012
- Last updated
- 2 May 2017
- Results posted
- No
Publications
Johansson 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.
PubMed 25117183
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01539655
- Acronym / sponsor ID
- Vandetanib / D4200C00101
- Conditions
- Medullary Thyroid Cancer
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, vandetanib, omeprazole, ranitidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vandetanib then vandetanib + omeprazole | Experimental | Drug: vandetanib, Drug: omeprazoleVandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 |
| vandetanib + omeprazole then vandetanib | Experimental | Drug: vandetanib, Drug: omeprazoleVandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 |
| vandetanib then vandetanib + ranitidine | Experimental | Drug: vandetanib, Drug: ranitidineVandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2 |
| vandetanib + ranitidine then vandetanib | Experimental | Drug: vandetanib, Drug: ranitidineVandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vandetanibOral tablets, 300 mg, single dose | Drug | vandetanib + omeprazole then vandetanib, vandetanib + ranitidine then vandetanib, vandetanib then vandetanib + omeprazole, vandetanib then vandetanib + ranitidine |
| omeprazoleOral capsules, 40 mg, multiple doses | Drug | vandetanib + omeprazole then vandetanib, vandetanib then vandetanib + omeprazole |
| ranitidineOral tables, 150 mg, multiple doses | Drug | vandetanib + ranitidine then vandetanib, vandetanib then vandetanib + ranitidine |
Primary outcome
Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
6 secondary outcomes
Frequency and severity of adverse events
Time frame: Treatment period + 7-14 days
ECG data
Time frame: Treatment period + 7-14 days
Laboratory data
Time frame: Treatment period + 7-14 days
Vital signs data
Time frame: Treatment period + 7-14 days
Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 25117183Johansson 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.
- Related InfoLink provided by the sponsor.
- CSR-D4200C00101.pdfLink provided by the sponsor.
- Revised\_CSP\_redactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vandetanib, omeprazole and ranitidine in people with Medullary Thyroid Cancer, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI) (time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.