HealthyPhase 1NCT01363804
A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Tivozanib in Healthy Subjects
A Phase 1 study testing Tivozanib in people with Healthy, run by AVEO Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile of tivozanib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tivozanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jul 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within the range of 18.5 to 31.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs.
- Clinical laboratory evaluations (including a chemistry panel comprised of 20 analytes [Chem-20, includes liver function tests; fasted approximately 10 hours], complete blood count [CBC], and urinalysis) not exceeding 2 x upper limit of normal (ULN) or < lower limit of normal (LLN), unless deemed not clinically significant by the Investigator.
- Nonsmokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to Screening), verified by a cotinine test at Screening and each study period Check-in.
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each study period Check-in (does include alcohol; Appendix A).
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- Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV] and negative human immunodeficiency virus [HIV] antibody screens; Appendix A).
- Females who are not pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile (eg, tubal ligation, hysterectomy) for at least 90 days prior to Screening, or agree to use at least 1 of the following forms of contraception from informed consent until 45 days after Study Completion: a non-hormonal intrauterine device with spermicide; female condom with spermicide; contraceptive sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide; a male sexual partner who agrees to use a male condom with spermicide; or a sterile sexual partner. For all females, a serum pregnancy test result must be negative at Screening and at each study period Check-in.
- Male subjects who are either sterile or agree to use, during the period from informed consent until 45 days following Study Completion, 1 of the following approved methods of contraception: a double barrier method (eg, male condom with spermicide, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, or use of a cervical cap with spermicide); a sterile sexual partner; a female sexual partner using an intravaginal system (eg, NuvaRing®); or a partner using an oral, implantable, transdermal, or injectable contraceptives.
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
Who cannot join
- Significant history or clinical manifestation of any significant metabolic/endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric disorder (as determined by the Investigator or Sponsor's Medical Monitor).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- History of stomach or intestinal surgery, nephrectomy, cholecystectomy, or resection that would potentially alter absorption and/or excretion of orally administered drugs as determined by the Investigator (appendectomy and/or hernia repair may be allowed).
- Diagnosis of alcoholism or drug addiction within 1 year prior to Period 1 Check-in.
- Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Period 1 Check-in.
- Use of any prescription medications or products within 14 days prior to Period 1 Check-in.
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- Use of any over-the-counter (OTC), non-prescription, systemic preparations (including vitamins, minerals, and phytotherapeutic, herbal, dietary supplements, or plant derived preparations) within 7 days prior to each study period Check-in.
- Consumption of food or beverages containing alcohol, grapefruit, Seville orange, or caffeine within 72 hours prior to each study period Check-in.
- Use of known hepatic or renal clearance altering agents (eg, rifampin, erythromycin, cimetidine, barbiturates, phenothiazines, or herbal/plant derived preparations such as St. John's Wort) for a period of 60 days prior to Period 1 Check-in and for the duration of the study.
- Poor peripheral venous access.
- Donation of blood ≥ 250 mL from 30 days prior to Period 1 Check-in until Study Completion, inclusive, or of plasma from 2 weeks prior to Period 1 Check-in until Study Completion, inclusive.
- Receipt of blood products within 2 months prior to Period 1 Check-in.
- Blood pressure greater than 140/90 mmHg confirmed by repeat at Screening or at Period 1 Check-in.
- Sensitivity to rifampin.
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Open-label, Two-period, Single-sequence Study to Evaluate the Effect of Rifampin on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Tivozanib in Healthy Subjects
This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile of tivozanib.
Read the detailed description
This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the effect of steady-state rifampin on the PK profile, safety, and tolerability of a single 1.5-mg tivozanib dose. On Day 1 of the first period, subjects will receive a single 1.5 mg dose of tivozanib, and remain at the unit for at least 48 hours postdose followed by outpatient visits for PK sampling and safety assessments up to 3 weeks postdose. For Period 2, subjects will be administered 600 mg of rifampin once daily (QD).for 6 days. On the 4th day of Period 2, 1.5mg of tivozanib will be administered with 600mg of rifampin. PK sampling will continue for 3-weeks postdose while the subjects continue to receive 600mg of rifampin daily. An end of study visit will be completed 1-week after the last dose of rifampin.
- Conditions
- Healthy
- Being tested
- Tivozanib
- Keywords
- AV-951, Tivozanib, Healthy Subjects, rifampin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TivozanibDrug
Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
| Study group | Role | What they receive |
|---|---|---|
| Tivozanib | Experimental | Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity. Receives: Drug: Tivozanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of steady-state rifampin on the pharmacokinetics (PK) of a single 1.5 mg tivozanib dose in healthy subjects.
Blood samples for PK analysis of serum tivozanib levels will be collected for a 3-week period following each dose.
Measured: Planned Enrollment/Screening Duration: Approximately 4 weeks.
To assess the safety and tolerability of tivozanib administered alone and in the presence of steady-state rifampin in healthy subjects.
Safety assessments will be completed by evaluation of physical exam, ECGs, laboratory assessments and adverse events
Measured: Planned Enrollment/Screening Duration: Approximately 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363804
- Sponsor's protocol ID
- AV-951-11-117
- Status last verified
- Jun 2012
- First submitted
- 31 May 2011
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Two-period, Single-sequence Study to Evaluate the Effect of Rifampin on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Tivozanib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01363804
- Acronym / sponsor ID
- AV-951-11-117
- Conditions
- Healthy
- Keywords
- AV-951, Tivozanib, Healthy Subjects, rifampin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Jun 2011 (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.
This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile of tivozanib.
Detailed description
This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the effect of steady-state rifampin on the PK profile, safety, and tolerability of a single 1.5-mg tivozanib dose. On Day 1 of the first period, subjects will receive a single 1.5 mg dose of tivozanib, and remain at the unit for at least 48 hours postdose followed by outpatient visits for PK sampling and safety assessments up to 3 weeks postdose. For Period 2, subjects will be administered 600 mg of rifampin once daily (QD).for 6 days. On the 4th day of Period 2, 1.5mg of tivozanib will be administered with 600mg of rifampin. PK sampling will continue for 3-weeks postdose while the subjects continue to receive 600mg of rifampin daily. An end of study visit will be completed 1-week after the last dose of rifampin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tivozanib | Experimental | Drug: TivozanibTivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or females, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within the range of 18.5 to 31.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs.
- Clinical laboratory evaluations (including a chemistry panel comprised of 20 analytes [Chem-20, includes liver function tests; fasted approximately 10 hours], complete blood count [CBC], and urinalysis) not exceeding 2 x upper limit of normal (ULN) or < lower limit of normal (LLN), unless deemed not clinically significant by the Investigator.
- Nonsmokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to Screening), verified by a cotinine test at Screening and each study period Check-in.
Key exclusion criteria (15 listed)
- Significant history or clinical manifestation of any significant metabolic/endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric disorder (as determined by the Investigator or Sponsor's Medical Monitor).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- History of stomach or intestinal surgery, nephrectomy, cholecystectomy, or resection that would potentially alter absorption and/or excretion of orally administered drugs as determined by the Investigator (appendectomy and/or hernia repair may be allowed).
- Diagnosis of alcoholism or drug addiction within 1 year prior to Period 1 Check-in.
- Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Period 1 Check-in.
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 |
|---|---|---|
| TivozanibTivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity. | Drug | Tivozanib |
Primary outcome
To examine the effect of steady-state rifampin on the pharmacokinetics (PK) of a single 1.5 mg tivozanib dose in healthy subjects.
Time frame: Planned Enrollment/Screening Duration: Approximately 4 weeks.
Blood samples for PK analysis of serum tivozanib levels will be collected for a 3-week period following each dose.
To assess the safety and tolerability of tivozanib administered alone and in the presence of steady-state rifampin in healthy subjects.
Time frame: Planned Enrollment/Screening Duration: Approximately 4 weeks.
Safety assessments will be completed by evaluation of physical exam, ECGs, laboratory assessments and adverse events
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 5 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tivozanib in people with Healthy, run by AVEO Pharmaceuticals, Inc. 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 10 inclusion and 15 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 5 Jun 2012. 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?
To examine the effect of steady-state rifampin on the pharmacokinetics (PK) of a single 1.5 mg tivozanib dose in healthy subjects. (time frame: Planned Enrollment/Screening Duration: Approximately 4 weeks.). 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?
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 5 Jun 2012.