HealthyPhase 1/2INX-189-005NCT01471704
Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
A Phase 1/2 study testing INX-08189 50 mg, 240 mg verapamil HCL ER and 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER). 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, 240 mg verapamil HCL ER and 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 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) and Visit 2 in order to be eligible for study drug administration:
- 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 be 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 Visit 2:
- 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 GI, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease;
- Clinically significant abnormalities on centrally read ECG including evidence of bradycardia (rate < 60 bpm) or evidence of PR prolongation;
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- Screening vital signs representing a heart rate of < 60 bpm, systolic blood pressure < 90 mm Hg, and diastolic blood pressure < 60 mm Hg;
- 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 2 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 (5) 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 or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with INX-08189;
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study;
- Consumption of grapefruit or grapefruit juice starting 48 hours before Study Day -1, during the subject's confinement in the unit, and during the outpatient follow-up periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Drug-Drug Interaction Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER).
Read the detailed description
This is a single-center, open-label, single-sequence, crossover, drug-drug interaction study in healthy subjects.
Primary Objectives:
Safety
- To evaluate the safety of a single dose of INX-08189 (50 mg) alone and combined with verapamil HCL ER (240 mg) after subjects receive verapamil HCL ER QD for 6 days
Pharmacokinetic
- To evaluate the effect of multiple doses of verapamil HCL ER (240 mg) on the pharmacokinetic (PK) profile of INX-08189 and the metabolite INX-08032, and the effect of a single dose of INX-08189 on the PK profile of verapamil and the metabolite norverapamil
- Conditions
- Healthy
- Being tested
- INX-08189 50 mg, 240 mg verapamil HCL ER, 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
- Keywords
- Pharmacokinetics, PK, INX08189, Verapamil, Inhibitex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INX-08189 50 mgDrug
Study Day 0: Single 50 mg dose of INX-08189 in the morning
240 mg verapamil HCL ERDrug
Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning
50 mg dose of INX-08189 and 240 mg verapamil HCL ERDrug
Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning
| Study group | Role | What they receive |
|---|---|---|
| INX-08189 50 mg | Experimental | Study Day 0: Single 50 mg dose of INX-08189 in the morning Receives: Drug: INX-08189 50 mg |
| 240 mg verapamil HCL ER | Active comparator | Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning Receives: Drug: 240 mg verapamil HCL ER |
| INX-08189 50 mg & verapamil HCLER 240 mg | Active comparator | Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning Receives: Drug: 50 mg dose of INX-08189 and 240 mg verapamil HCL ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of multiple doses of verapamil HCL ER 240 mg on the PK profile of INX-08189, and the effect of a single dose of INX-08189 on the PK profile of verapamil.
PK for INX-08189 and verapamil by: maximum plasma concentration (Cmax), time Cmax is observed (Tmax), plasma concentration at end of dosing (Ctau), area under plasma concentration-time curve; time 0 to last measurable plasma concentration (AUC0-last), area under plasma concentration-time curve; time 0 to infinity (AUC0-inf), area under plasma concentration-time curve; 0 to end of dosing (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F).
Measured: INX-08189 and Verapamil: Study Day 0 (INX-08189), Study Day 12 (Verapamil) and subsequently at 30 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours after dosing. INX-08189 also at 48, 72, and 96 hours after initial dose.
Safety of a single dose of INX-08189 50 mg alone & combined with verapamil HCL ER 240 mg after subjects received verapamil HCL ER QD for 6 days
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, electrocardiogram (ECG) and vital signs assessments
Measured: Study Day -1, during the 24-hours post-dose, Study Day 2 to 4, 5, 6, 7 to 11, 12, and 13 to 16
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01471704
- Sponsor's protocol ID
- AI472-005
- Other IDs
- INH-189-005
- Acronym
- INX-189-005
- 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 1b, Drug-Drug Interaction Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01471704
- Acronym / sponsor ID
- INX-189-005 / AI472-005
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, PK, INX08189, Verapamil, Inhibitex
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 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.
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER).
Detailed description
This is a single-center, open-label, single-sequence, crossover, drug-drug interaction study in healthy subjects.
Primary Objectives:
Safety
- To evaluate the safety of a single dose of INX-08189 (50 mg) alone and combined with verapamil HCL ER (240 mg) after subjects receive verapamil HCL ER QD for 6 days
Pharmacokinetic
- To evaluate the effect of multiple doses of verapamil HCL ER (240 mg) on the pharmacokinetic (PK) profile of INX-08189 and the metabolite INX-08032, and the effect of a single dose of INX-08189 on the PK profile of verapamil and the metabolite norverapamil
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INX-08189 50 mg | Experimental | Drug: INX-08189 50 mgStudy Day 0: Single 50 mg dose of INX-08189 in the morning |
| 240 mg verapamil HCL ER | Active comparator | Drug: 240 mg verapamil HCL ERStudy Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning |
| INX-08189 50 mg & verapamil HCLER 240 mg | Active comparator | Drug: 50 mg dose of INX-08189 and 240 mg verapamil HCL ERStudy Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning |
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) and Visit 2 in order to be eligible for study drug administration:
- 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 (17 listed)
- Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Visit 2:
- 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 GI, 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 mgStudy Day 0: Single 50 mg dose of INX-08189 in the morning | Drug | INX-08189 50 mg |
| 240 mg verapamil HCL ERStudy Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning | Drug | 240 mg verapamil HCL ER |
| 50 mg dose of INX-08189 and 240 mg verapamil HCL ERStudy Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning | Drug | INX-08189 50 mg & verapamil HCLER 240 mg |
Primary outcome
Effect of multiple doses of verapamil HCL ER 240 mg on the PK profile of INX-08189, and the effect of a single dose of INX-08189 on the PK profile of verapamil.
Time frame: INX-08189 and Verapamil: Study Day 0 (INX-08189), Study Day 12 (Verapamil) and subsequently at 30 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours after dosing. INX-08189 also at 48, 72, and 96 hours after initial dose.
PK for INX-08189 and verapamil by: maximum plasma concentration (Cmax), time Cmax is observed (Tmax), plasma concentration at end of dosing (Ctau), area under plasma concentration-time curve; time 0 to last measurable plasma concentration (AUC0-last), area under plasma concentration-time curve; time 0 to infinity (AUC0-inf), area under plasma concentration-time curve; 0 to end of dosing (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F).
Safety of a single dose of INX-08189 50 mg alone & combined with verapamil HCL ER 240 mg after subjects received verapamil HCL ER QD for 6 days
Time frame: Study Day -1, during the 24-hours post-dose, Study Day 2 to 4, 5, 6, 7 to 11, 12, and 13 to 16
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, electrocardiogram (ECG) and vital signs 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, 240 mg verapamil HCL ER and 50 mg dose of INX-08189 and 240 mg verapamil HCL ER 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 17 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. 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?
Effect of multiple doses of verapamil HCL ER 240 mg on the PK profile of INX-08189, and the effect of a single dose of INX-08189 on the PK profile of verapamil. (time frame: INX-08189 and Verapamil: Study Day 0 (INX-08189), Study Day 12 (Verapamil) and subsequently at 30 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours after dosing. INX-08189 also at 48, 72, and 96 hours after initial 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.