NL-OMON51387
Completed
Not Applicable
A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens - JNJ-64281802 Multiple Dose Regimens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 18 to 55 years of age, extremes included, at the time of screening.
- •2\. Healthy on the basis of physical examination, medical history (at screening
- •only), and vital signs performed at screening and Day \-1\. If
- •there are abnormalities, 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.
- •3\. Healthy on the basis of clinical laboratory tests performed at screening and
- •Day \-1\. If the results of the serum chemistry panel, blood
- •coagulation, hematology, or urinalysis are outside the normal reference ranges
Exclusion Criteria
- •1\. History of or current clinically significant medical illness including (but
- •not limited to) cardiac arrhythmias (eg, extrasystole, tachycardia at rest) or
- •other cardiac disease, risk factors for Torsade de Pointes syndrome (eg,
- •hypokalemia, family history of long QT Syndrome), hematologic disease,
- •coagulation disorders (including any abnormal bleeding or blood dyscrasias),
- •lipid abnormalities, significant pulmonary disease, including bronchospastic
- •respiratory disease, diabetes mellitus,
- •hepatic or renal insufficiency (creatinine clearance below 60 mL/min at
- •screening, calculated by the Modification of Diet in Renal Disease \[MDRD]
- •formula, vascular, gastrointestinal (such as significant diarrhea, gastric
Outcomes
Primary Outcomes
Not specified
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