A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants

NCT02355561 | Completed Phase 1

• 3 other identifiers: CR1066212014-004251-3154861911ALZ1011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation in healthy elderly participants.

Conditions

Healthy

Keywords

Bioavailability; Healthy Participants; JNJ-54861911; Food Effect

Outcome Measures

Primary Outcomes (8)

• Maximum Plasma Concentration (Cmax) of JNJ-54861911

  The Cmax is the maximum observed plasma concentration of JNJ-54861911.

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

• Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911

  The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 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

  The AUC (0-t) calculated by trapezoidal summation \[time t is the time of the last quantifiable concentration (C\[last\])\].

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

• Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-54861911

  The AUC (0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 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

  The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-54861911 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

• Elimination Rate Constant (Lambda [z]) of JNJ-54861911

  The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

• Terminal Half-life (t[1/2]) of JNJ-54861911

  The t(1/2) is defined as 0.693/Lambda (z).

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

• Relative Bioavailability (F[rel]) of JNJ-54861911

  Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).

  Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Serious AEs

  Screening up to follow-up (7 to 14 days after last dose administration)

Study Arms (6)

Sequence 1 (ABC)

EXPERIMENTAL

Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram \[mg\] formulation 1 \[reference\] under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg formulation 2 \[test\] under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg formulation 2 under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Sequence 2 (ACB)

EXPERIMENTAL

Participants will receive Treatment A in Period 1; followed by Treatment C in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Sequence 3 (BAC)

EXPERIMENTAL

Participants will receive Treatment B in Period 1; followed by Treatment A in Period 2; followed by Treatment C in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Sequence 4 (BCA)

EXPERIMENTAL

Participants will receive Treatment B in Period 1; followed by Treatment C in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Sequence 5 (CAB)

EXPERIMENTAL

Participants will receive Treatment C in Period 1; followed by Treatment A in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Sequence 6 (CBA)

EXPERIMENTAL

Participants will receive Treatment C in Period 1; followed by Treatment B in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

Interventions

JNJ-54861911 (Treatment A) DRUG

Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

JNJ-54861911 (Treatment B) DRUG

Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

JNJ-54861911 (Treatment C) DRUG

Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a body mass index (BMI) between 18 and 30 Kilogram (kg)/Meter (m)\^2, inclusive (BMI = weight/height\^2)
• Participant must 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 and admission. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
• Participants must 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 participant's 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 e.g., 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 90 days 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. Effective methods of contraception include prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch

You may not qualify if:

• Participant has clinically significant abnormal findings in physical exam, vital signs or 12-lead ECG incl. QTcF greater than (\>) 450 milliseconds (ms) for males and females, Left Bundle Branch Block, Atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD) at Screening or admission, which in the opinion of the investigator are not appropriate and reasonable for the population under study
• Participant has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
• Participant has a history of or current renal \[Estimated glomerular filtration rate (eGFR) less than (\<) 60 based on Modification of diet in renal diseases (MDRD) formula\] or hepatic insufficiency
• Participant has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

atabecestat

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

BE (1)