HealthyPhase 1/2INX-189-004NCT01471717
Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
A Phase 1/2 study testing INX-08189 50 mg QD X 5 days, INX-08189 / Victrelis 800 mg TID X three days and Victrelis 800 mg TID x 3 days in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA). 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?
- INX-08189 50 mg QD X 5 days, INX-08189 / Victrelis 800 mg TID X three days and Victrelis 800 mg TID x 3 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2011
- Phase
- Phase 1/2
- 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
- Subjects must meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3):
- Must be a healthy male or female between 18 and 55 years of age (inclusive) with body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and weigh ≥ 50 kg at the time of signing the informed consent;
- Capable of giving written informed consent that includes compliance with the requirements and restrictions listed in the consent form. Signed informed consent must be on file prior to screening procedures;
- Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
- Must be a non-tobacco user for at least 3 months prior to selection;
- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening;
- Women must be postmenopausal for at least 2 years or be surgically sterile with complete hysterectomy or bilateral oophorectomy, and not be pregnant nor breastfeeding;
- Male subjects, who are not surgically sterile with vasectomy, must agree to use a double barrier method of birth control, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository). This criterion must be followed from the time of the first dose of study medication until 30 days after the last dose of medication. Male subjects cannot donate sperm during the study and for 3 months after receiving the last dose of the study drug.
Who cannot join
- Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3):
- Infection with Hepatitis A, B or C Virus;
- Infection with the Human Immunodeficiency Virus (HIV);
- History of or any current medical condition which could impact the safety of the participant in the study;
- Current active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease;
- Clinically significant abnormalities on centrally read ECG;
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- Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability;
- Safety laboratory abnormalities at screening which are clinically significant, or absolute neutrophil count of < 1800 cells/mm3, or platelet count < 130,000 cells/mm3, or hemoglobin < 12 g/dl for women and < 13 g/dl for men;
- Women of child bearing potential;
- Pregnant or breastfeeding;
- Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years;
- A positive urine drug test at screening;
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25ml shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 ml servings of coffee or other caffeinated beverages per day;
- Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications, including vitamins, within 7 days of starting the study;
- Received an investigational drug or vaccine within 30 days or 5 half lives, whichever is longer, from the receipt of a small molecule or 90 days or 5 half lives, whichever is longer, from the receipt of a large biological molecule prior to Study Day 0, or used an investigational medical device within 30 days prior to Study Day 0, or having participated previously in a study with INX-08189.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Single-Center, Randomized, Two-Sequence, Placebocontrolled, Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
Read the detailed description
This is a single-center, randomized, placebo-controlled study in thirty-two 18 to 55 year old, male and female, healthy adult volunteers.
Primary Objectives:
Pharmacokinetic
- To characterize the pharmacokinetic (PK) profile of INX-08189 and INX-08032 when INX-08189 is dosed alone as compared to when dosed in combination with Victrelis
- To characterize the PK profile of Victrelis when dosed alone as compared to when dosed in combination with INX-08189
Safety
- To evaluate the safety of INX-08189 and Victrelis when dosed alone and when dosed in combination
- Conditions
- Healthy
- Being tested
- INX-08189 50 mg QD X 5 days, INX-08189 / Victrelis 800 mg TID X three days, Victrelis 800 mg TID x 3 days, Victrelis 800 mg TID with INX-08189 50 mg QD, Placebo with Victrelis 800 mg
- Keywords
- PK, pharmacokinetics, INX08189, Victrelis, Inhibitex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INX-08189 50 mg QD X 5 daysDrug
Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose.
INX-08189 / Victrelis 800 mg TID X three daysDrug
Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7)
Victrelis 800 mg TID x 3 daysDrug
In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2).
Victrelis 800 mg TID with INX-08189 50 mg QDDrug
Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7).
Placebo with Victrelis 800 mgDrug
During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Cohort 2: Victrelis 800 mg with PlaceboDrug
During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
| Study group | Role | What they receive |
|---|---|---|
| C 1:INX-08189 50 mg qd X 5 days | Experimental | Cohort 1: Subjects will begin administration of INX-08189 50 mg every day (QD) on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose. Receives: Drug: INX-08189 50 mg QD X 5 days |
| C1: INX-08189 / Victrelis 800 mg TID X 3 days | Active comparator | Cohort 1:INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg three times a day (TID) for 3 additional days Receives: Drug: INX-08189 / Victrelis 800 mg TID X three days |
| C2: Victrelis 800 mg TID x 3 days | Active comparator | Cohort 2: Subjects will begin administration of Victrelis 800 mg three times a day (TID) on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days Receives: Drug: Victrelis 800 mg TID x 3 days |
| C 2:Victrelis 800 mg TID with INX-08189 50 mg QD | Active comparator | Cohort 2: Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days Receives: Drug: Victrelis 800 mg TID with INX-08189 50 mg QD |
| C1: Placebo with Victrelis 800 mg | Placebo comparator | Cohort 1: Placebo QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days Receives: Drug: Placebo with Victrelis 800 mg |
| C 2: Victrelis 800 mg with Placebo | Placebo comparator | Cohort 2: Victrelis 800 mg TID will be administered concurrently with Placebo QD for 5 additional days Receives: Drug: Cohort 2: Victrelis 800 mg with Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination: maximum observed plasma concentration (Cmax), time at which Cmax is observed (Tmax), plasma concentration at the end of dosing interval (Ctau), area under the plasma concentration-time curve from time 0 to the end of dosing interval (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F), as applicable
Measured: INX-08189: C1: Days 4 & 7; C2: Day 7 pre-dose & 15, 30, & 45 minutes, & 1, 2, 3, 4, 6, 8, 10, 12, 16, & 24 hours after dosing. Victrelis: C2: Days 2 & 7; C1: Day 7 pre-dose & 0.5, 1, 2, 3, 4, 6, & 8 hours after AM dose. Up to 72 hours after last dose.
Safety parameters, including adverse event, concurrent medication, clinical laboratory, ECG, PE, and VS assessments
Safety will be monitored by PEs, VS, clinical laboratory tests (including blood chemistry, CBC with differential, Troponin I, creatinine phosphokinase, and urinalysis), ECGs, and AE assessments.
Measured: Study Day 1 to 8, and Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 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.
- More trials run by Bristol-Myers SquibbThe 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Campaneria, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471717
- Sponsor's protocol ID
- AI472-004
- Other IDs
- INX-189-004
- Acronym
- INX-189-004
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Single-Center, Randomized, Two-Sequence, Placebocontrolled, Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01471717
- Acronym / sponsor ID
- INX-189-004 / AI472-004
- Conditions
- Healthy
- Keywords
- PK, pharmacokinetics, INX08189, Victrelis, Inhibitex
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Nov 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 potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
Detailed description
This is a single-center, randomized, placebo-controlled study in thirty-two 18 to 55 year old, male and female, healthy adult volunteers.
Primary Objectives:
Pharmacokinetic
- To characterize the pharmacokinetic (PK) profile of INX-08189 and INX-08032 when INX-08189 is dosed alone as compared to when dosed in combination with Victrelis
- To characterize the PK profile of Victrelis when dosed alone as compared to when dosed in combination with INX-08189
Safety
- To evaluate the safety of INX-08189 and Victrelis when dosed alone and when dosed in combination
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C 1:INX-08189 50 mg qd X 5 days | Experimental | Drug: INX-08189 50 mg QD X 5 daysCohort 1: Subjects will begin administration of INX-08189 50 mg every day (QD) on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose. |
| C1: INX-08189 / Victrelis 800 mg TID X 3 days | Active comparator | Drug: INX-08189 / Victrelis 800 mg TID X three daysCohort 1:INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg three times a day (TID) for 3 additional days |
| C2: Victrelis 800 mg TID x 3 days | Active comparator | Drug: Victrelis 800 mg TID x 3 daysCohort 2: Subjects will begin administration of Victrelis 800 mg three times a day (TID) on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days |
| C 2:Victrelis 800 mg TID with INX-08189 50 mg QD | Active comparator | Drug: Victrelis 800 mg TID with INX-08189 50 mg QDCohort 2: Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days |
| C1: Placebo with Victrelis 800 mg | Placebo comparator | Drug: Placebo with Victrelis 800 mgCohort 1: Placebo QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days |
| C 2: Victrelis 800 mg with Placebo | Placebo comparator | Drug: Cohort 2: Victrelis 800 mg with PlaceboCohort 2: Victrelis 800 mg TID will be administered concurrently with Placebo QD for 5 additional days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3):
- Must be a healthy male or female between 18 and 55 years of age (inclusive) with body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and weigh ≥ 50 kg at the time of signing the informed consent;
- Capable of giving written informed consent that includes compliance with the requirements and restrictions listed in the consent form. Signed informed consent must be on file prior to screening procedures;
- Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
- Must be a non-tobacco user for at least 3 months prior to selection;
Key exclusion criteria (15 listed)
- Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3):
- Infection with Hepatitis A, B or C Virus;
- Infection with the Human Immunodeficiency Virus (HIV);
- History of or any current medical condition which could impact the safety of the participant in the study;
- Current active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease;
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 |
|---|---|---|
| INX-08189 50 mg QD X 5 daysCohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose. | Drug | C 1:INX-08189 50 mg qd X 5 days |
| INX-08189 / Victrelis 800 mg TID X three daysCohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7) | Drug | C1: INX-08189 / Victrelis 800 mg TID X 3 days |
| Victrelis 800 mg TID x 3 daysIn Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2). | Drug | C2: Victrelis 800 mg TID x 3 days |
| Victrelis 800 mg TID with INX-08189 50 mg QDVictrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7). | Drug | C 2:Victrelis 800 mg TID with INX-08189 50 mg QD |
| Placebo with Victrelis 800 mgDuring combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food. | Drug | C1: Placebo with Victrelis 800 mg |
| Cohort 2: Victrelis 800 mg with PlaceboDuring combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food. | Drug | C 2: Victrelis 800 mg with Placebo |
Primary outcome
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination
Time frame: INX-08189: C1: Days 4 & 7; C2: Day 7 pre-dose & 15, 30, & 45 minutes, & 1, 2, 3, 4, 6, 8, 10, 12, 16, & 24 hours after dosing. Victrelis: C2: Days 2 & 7; C1: Day 7 pre-dose & 0.5, 1, 2, 3, 4, 6, & 8 hours after AM dose. Up to 72 hours after last dose.
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination: maximum observed plasma concentration (Cmax), time at which Cmax is observed (Tmax), plasma concentration at the end of dosing interval (Ctau), area under the plasma concentration-time curve from time 0 to the end of dosing interval (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F), as applicable
Safety parameters, including adverse event, concurrent medication, clinical laboratory, ECG, PE, and VS assessments
Time frame: Study Day 1 to 8, and Study Day 14
Safety will be monitored by PEs, VS, clinical laboratory tests (including blood chemistry, CBC with differential, Troponin I, creatinine phosphokinase, and urinalysis), ECGs, and AE assessments.
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 22 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.
Ralph Campaneria, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INX-08189 50 mg QD X 5 days, INX-08189 / Victrelis 800 mg TID X three days and Victrelis 800 mg TID x 3 days in people with Healthy, run by Bristol-Myers Squibb 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 8 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 22 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination (time frame: INX-08189: C1: Days 4 & 7; C2: Day 7 pre-dose & 15, 30, & 45 minutes, & 1, 2, 3, 4, 6, 8, 10, 12, 16, & 24 hours after dosing. Victrelis: C2: Days 2 & 7; C1: Day 7 pre-dose & 0.5, 1, 2, 3, 4, 6, & 8 hours after AM dose. Up to 72 hours after last 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?
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 22 Jun 2012.