Healthy VolunteersPhase 1VandetanibNCT01544140
Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
A Phase 1 study testing Midazolam and vandetanib in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Midazolam and vandetanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 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
Show all 11Show fewer
- Any positive result on screening for:
- serum hepatitis B surface antigen,
- hepatitis C antibody, and
- 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, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Dose of 800-mg Vandetanib (CAPRELSA)
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
Read the detailed description
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)
- Conditions
- Healthy Volunteers
- Being tested
- Midazolam, vandetanib
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, vandetanib, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Oral syrup 7.5 mg, single dose
vandetanibDrug
Oral tablets, 800 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| midazolam then midazolam + vandetanib | Experimental | Midazolam alone followed by midazolam in combination with vandetanib Receives: Drug: Midazolam; Drug: vandetanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for midazolam administered alone and in combination with vandetanib 800 mg
Measured: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Cmax for midazolam administered alone and in combination with vandetanib 800 mg
Measured: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Secondary outcomes (6)
Frequency and severity of adverse events
Measured: Treatment period from 7 to 14 days
ECG data
Measured: Treatment period from 7 to 14 days
Laboratory data
Measured: Treatment period from 7 to 14 days
Vital signs data
Measured: Treatment period from 7 to 14 days
Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg
Measured: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Vandetanib PK parameters for vandetanib in combination with midazolam
Measured: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216 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 posted5 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 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 Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01544140
- Sponsor's protocol ID
- D4200C00103
- Acronym
- Vandetanib
- Status last verified
- Aug 2016
- First submitted
- 23 Feb 2012
- Last updated
- 29 Aug 2016
- 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 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Dose of 800-mg Vandetanib (CAPRELSA)
- ClinicalTrials.gov ID
- NCT01544140
- Acronym / sponsor ID
- Vandetanib / D4200C00103
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, vandetanib, midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Mar 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.
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
Detailed description
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| midazolam then midazolam + vandetanib | Experimental | Drug: Midazolam, Drug: vandetanibMidazolam alone followed by midazolam in combination with vandetanib |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study
- specific procedures:
Key exclusion criteria (11 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 |
|---|---|---|
| MidazolamOral syrup 7.5 mg, single dose | Drug | midazolam then midazolam + vandetanib |
| vandetanibOral tablets, 800 mg, single dose | Drug | midazolam then midazolam + vandetanib |
Primary outcome
AUC for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Cmax for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
6 secondary outcomes
Frequency and severity of adverse events
Time frame: Treatment period from 7 to 14 days
ECG data
Time frame: Treatment period from 7 to 14 days
Laboratory data
Time frame: Treatment period from 7 to 14 days
Vital signs data
Time frame: Treatment period from 7 to 14 days
Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Vandetanib PK parameters for vandetanib in combination with midazolam
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216 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 29 Aug 2016.
- 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-D4200C00103.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 Midazolam and vandetanib in people with Healthy Volunteers, 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 5 inclusion and 11 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 29 Aug 2016. 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?
AUC for midazolam administered alone and in combination with vandetanib 800 mg (time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose). The study lists 2 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 NCT01544140, 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 29 Aug 2016.