A Study to Assess the Effect of Multiple-Dose Administration of JNJ-42847922 on Midazolam and Warfarin in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/21/2016 |
Start Date: | November 2015 |
End Date: | February 2016 |
An Open-Label Drug Interaction Study to Assess the Effect of Multiple-Dose Administration of JNJ-42847922 on the Single-Dose Pharmacokinetics of Midazolam and the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
The purpose of this study is to evaluate effect of multiple-dose administration of
JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose
pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of
racemic warfarin.
JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose
pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of
racemic warfarin.
This is an open-label (all people know the identity of the intervention), single-center,
fixed-sequence, study of JNJ-42847922 in healthy participants. The study consists of 3
Phases: Screening Phase (28 Days), open-label treatment Phase (40 Days) and follow up visit
(7 to 14 Days after last study procedure). The duration of participation in the study for
each participant is approximately 82 Days. Participants' safety will be monitored throughout
the study.
fixed-sequence, study of JNJ-42847922 in healthy participants. The study consists of 3
Phases: Screening Phase (28 Days), open-label treatment Phase (40 Days) and follow up visit
(7 to 14 Days after last study procedure). The duration of participation in the study for
each participant is approximately 82 Days. Participants' safety will be monitored throughout
the study.
Inclusion Criteria:
- Signed an informed consent document indicating they understand the purpose of and
procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in protocol
- If a woman, must be not of child-bearing potential: postmenopausal [greater than or
equal to (>=) 45 years of age with amenorrhea for at least 2 years, or any age with
amenorrhea for at least 6 months and a serum stimulating hormone (FSH) greater than
(>) 40 International units per liter (IU/L), or surgically sterile (example,
hysterectomy, oophorectomy, tubal ligation or tubal occlusion)
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction for at least 3 months after the last dose of study drug
- If a man who is sexually active with a woman of childbearing potential and has not
had a vasectomy, must agree to use an adequate contraception method as deemed
appropriate by the Investigator (example, vasectomy, double-barrier, partner using
effective contraception) and to not donate sperm during the study and for 3 months
after receiving the last dose of study drug
- Body mass index (BMI) between 18 and 30 kilogram (kg)/meter^2 (m^2), and body weight
not less than 50 kg
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), syncope,
hypotension, hypertension or vascular disorders, lipid abnormalities, significant
pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus,
hepatic or renal insufficiency, kidney or urinary tract disturbances, thyroid
disease, neurologic disease, significant psychiatric disorder, epilepsy, or fits of
unexplained black-outs, infection, or any other illness that the Investigator
considers should exclude the participant or that could interfere with the
interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry,
urinalysis, or thyroid stimulating hormone (TSH) at Screening or at Day -1 of the
first treatment period as deemed appropriate by the Investigator. In addition,
participants must have coagulation test results [(prothrombin time (PT),
international normalized ratio (INR), and activated partial thromboplastin time
(aPTT)] within clinically acceptable limits at Screening as deemed appropriate by the
Investigator
- Clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) at Screening or Day -1 of the first treatment period as
deemed appropriate by the Investigator
- Participants who are homozygous or heterozygous for CYP2C9*2 or CYP2C9*3 alleles
- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, within 14 days before the first dose of the
study drug is scheduled until completion of the study. In addition, participants will
be excluded if they have used medications known to affect coagulation or modulate
CYP2C9 or VKORC1 within 28 days of study admission
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