NL-OMON50152
Completed
Not Applicable
A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants - Drug-drug Interaction of Multiple-dose JNJ-64417184
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female, 18 to 54 years of age, extremes included, at screening.
- •2\. Must have a body mass index between 18\.0 and 30\.0 kg/m2, extremes included,
- •and body weight not less than 50\.0 kg at screening.
- •3\. Healthy on the basis of physical examination, medical and surgical history,
- •and vital signs performed at screening. If there are abnormalities other than
- •those listed in Exclusion Criteria 2 and 3, the participant may be included
- •only if the investigator judges the abnormalities to be not clinically
- •significant or to be appropriate and reasonable for the population under study.
- •This determination must be recorded in the participant's source documents and
- •initialed by the investigator.
Exclusion Criteria
- •1\. History of liver or renal dysfunction (calculated creatinine
- •clearance/estimated glomerular filtration rate (eGFR) \<60 mL/min at screening,
- •calculated by the Modification of Diet in Renal Disease \[MDRD] formula),
- •significant cardiac, vascular, pulmonary, gastrointestinal (such as significant
- •diarrhea, gastric stasis, or constipation that in the investigator\*s opinion
- •could influence drug absorption or bioavailability), endocrine, neurologic,
- •hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
- •2\. Past history of clinically significant cardiac arrhythmias (eg,
- •extrasystoli, tachycardia at rest), history of risk factors for Torsade de
- •Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
A Phase I, open-label, randomized, 2-way crossover trial in 40 healthy subjects to investigate the potential pharmacokinetic interactions between telaprevir and darunavir/ritonavir and between telaprevir and fosamprenavir/ritonavir at steady-statehepatitis C / liver disease10047438NL-OMON32330TIBOTEC PHARMACEUTICALS In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO40
Not yet recruiting
Not Applicable
A Phase I, open-label, randomized, 2-way crossover trial in 2 parallel panels of 20 healthy subjects each to investigate the pharmacokinetic interaction between lopinavir/ritonavir (LPV/rtv) and telaprevir, and between atazanavir/ritonavir (ATV/rtv) and telaprevir, all at steady-state.NL-OMON30839Tibotec Pharmaceuticals40
Suspended
Phase 1
To evaluate Safety and Pharmacokinetics of Briogyn (Follitropin alfa, Cadila HealthCare)CTRI/2020/12/029469PSK Pharma LLC
Completed
Not Applicable
A Phase I, open-label, randomized, two-way crossover study to investigate the effects of morning versus evening repeated dosing on the pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in healthy female subjects.NL-OMON44378Galapagos N.V.10
Completed
Not Applicable
A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Subjectscold virusRespiratory syncytial virus10024970NL-OMON48293Janssen-Cilag International NV16