Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: INX-08189 50 mg (Drug); 240 mg verapamil HCL ER (Drug); 50 mg dose of INX-08189 and 240 mg verapamil HCL ER (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Ralph Campaneria, MD, Study Director
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).
Clinical Details
Official title: A Phase 1b, Drug-Drug Interaction Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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.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
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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Subjects must meet the following criteria at the screening visit (Visit1) and Visit 2 in
order to be eligible for study drug administration:
1. 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;
2. 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;
3. Subject is able to understand and comply with the protocol requirements, instructions
and restrictions;
4. Must be a non-tobacco user for at least 3 months prior to selection;
5. Healthy on the basis of physical examination, medical history, vital signs,
electrocardiogram and clinical laboratory tests at screening;
6. 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;
7. 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.
Exclusion Criteria:
Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to
be eligible for study drug administration at Visit 2:
1. Infection with Hepatitis A, B or C Virus;
2. Infection with the Human Immunodeficiency Virus (HIV);
3. History of or any current medical condition which could impact the safety of the
participant in the study;
4. Current active or underlying GI, cardiovascular, neurologic, psychiatric, metabolic,
renal, hepatic, respiratory, inflammatory, or infectious disease;
5. Clinically significant abnormalities on centrally read ECG including evidence of
bradycardia (rate < 60 bpm) or evidence of PR prolongation;
6. Screening vital signs representing a heart rate of < 60 bpm, systolic blood pressure
< 90 mm Hg, and diastolic blood pressure < 60 mm Hg;
7. Currently significant diarrhea, gastric stasis, or constipation that in the
investigator's opinion could influence drug absorption or bioavailability;
8. 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;
9. Women of child bearing potential, pregnant or breastfeeding;
10. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug
abuse within the preceding 2 years;
11. A positive urine drug test at screening;
12. 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;
13. 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;
14. 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;
15. 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;
16. 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.
Locations and Contacts
Prism Research, LLC, St Paul, Minnesota 55114, United States
Additional Information
Starting date: October 2011
Last updated: June 21, 2012
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