A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/23/2019 |
| Start Date: | April 9, 2019 |
| End Date: | July 1, 2019 |
| Contact: | Study Contact |
| Email: | JNJ.CT@sylogent.com |
| Phone: | 844-434-4210 |
A Phase 1, Open-label Study to Determine the Absorption, Metabolism, and Routes of Excretion, Following Oral Administration of (14C) Radiolabeled JNJ-56136379 in Healthy Male Subjects
The purpose of this study is to investigate the absorption, the metabolic pathways, the route
and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived
radioactivity in healthy male adult participants after administration of a single oral dose
of 14C-JNJ-56136379.
and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived
radioactivity in healthy male adult participants after administration of a single oral dose
of 14C-JNJ-56136379.
Inclusion Criteria:
- During the study (from the day of study drug intake onwards) and for a minimum of 1
spermatogenesis cycle (defined as approximately 90 days) after receiving study drug, a
male participant: must agree: (a) to wear a condom when engaging in any activity that
allows for passage of ejaculate to another person (male participant should also be
advised of the benefit for a female partner to use a highly effective method of
contraception as condom may break or leak); (b) not to donate sperm for the purpose of
reproduction.
Contraceptive use should be consistent with local regulations regarding the use of
contraceptive methods for participants participating in clinical studies
- Must have a body mass index (BMI; weight [kg]/height^2 [m]^2) between 18.0 and 30.0
kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50
kilogram (kg) at screening
- Healthy on the basis of physical examination, medical history and surgical history,
and vital signs performed at screening. 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 and initialed by
the investigator
- Healthy on the basis of clinical laboratory tests performed at screening
- Must have a normal 12-lead electrocardiogram (ECG) at screening
Exclusion Criteria:
- Any evidence of heart block or bundle branch block at screening
- Human immunodeficiency virus 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at
screening
- History of hepatitis A, B, C, or E infection, or current hepatitis A infection
(confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV)
infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV)
infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by
hepatitis E [HEV] antibody IgM [in case HEV IgM positive, a confirmatory HEV
ribonuclic acid {RNA} test should be performed]) at screening
- Any current, or history of, confirmed clinically significant skin disease requiring
intermittent or chronic treatment such as, but not limited to, dermatitis, eczema,
drug rash, psoriasis, food allergy, and urticaria
- A history of clinically significant drug allergy such as, but not limited to,
sulfonamides and penicillins, or drug allergy witnessed in previous studies with
experimental drugs
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