A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02260700
• Date of registration: 06/10/2014
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants
• Scientific title: A Randomized, Open-Label, 3-Way Crossover Study in Healthy Older Male Subjects to Evaluate the Bioavailability, Food Effect, Safety and Tolerability of A Solid Dosage Formulation of JNJ-54861911
• Date of first enrolment: September 2013
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02260700
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between 18
and 30 kg/m^2, (inclusive)

- Be healthy for their age group with or without medication on the basis of physical
examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)
performed at Screening or admission. Minor deviations in ECG, which are not
considered to be of clinical significance to the investigator, are acceptable

- Be healthy on the basis of clinical laboratory tests performed at Screening. If the
results of the serum chemistry panel [including liver enzymes], hematology, or
urinalysis are outside the normal reference ranges, the participant may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant. This determination must be recorded in the participants'
source documents and initialed by the investigator

- Men who are sexually active with a woman of childbearing potential and have not had a
vasectomy must agree to use a barrier method of birth control for example, either
condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap
(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository,
and all men must also not donate sperm during the study and for 3 months after
receiving the last dose of study drug. In addition, their female partners should also
use an appropriate method of birth control for at least the same duration

- Participants' must have signed an informed consent document indicating that they
understand the purpose of and procedures required for the study and are willing to
participate in the study

Exclusion Criteria:

- Participant has a clinically significant abnormal physical examination, vital signs
or 12 lead ECG (including QTc greater than (>) 450msec, Left Bundle Branch Block,
permanent pacemaker or implantable cardioverter defibrillator) at Screening or
admission

- Participant has a history of or current liver or renal insufficiency; significant
cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
rheumatologic, psychiatric, or metabolic disturbances

- Use of any prescription or over-the-counter medication, herbal medication, vitamins,
or mineral supplements within 14 days prior to study drug administration (not
including paracetamol). Medication for chronic use in age related disease will be
allowed after approval by both the investigator and to the sponsor. No change in dose
or regimen will be permitted during the study that is, from the Screening visit until
the follow-up visit

- Participant has a history of spontaneous, prolonged or severe bleeding of unclear
origin

- Participant has a history of epilepsy or fits or unexplained black-outs other than
vasovagal collapse



Age minimum: 55 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-54861911 (Treatment B)

Drug: JNJ-54861911 (Treatment C)

Drug: JNJ-54861911 (Treatment A)

Primary Outcome(s)

Rate of Absorption of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Elimination Rate Constant (Lambda [z]) of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Maximum Plasma Concentration (Cmax) of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Extent of Absorption of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Terminal Half-life (t[1/2]) of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Relative Bioavailability (F[rel]) of JNJ-54861911 [Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period]

Secondary Outcome(s)

Number of Participants with Adverse Events (AEs) and Serious AEs [Time Frame: Screening up to follow-up (7 to 14 days after last dose administration)]

Secondary ID(s)

2013-002650-70

54861911ALZ1003

CR102380

Source(s) of Monetary Support

Please refer to primary and secondary sponsors