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HealthyPhase 1NCT02837692

A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults

A Phase 1 study testing JNJ-42847922 10 milligram (mg), JNJ-42847922 20 mg and JNJ-42847922 40 mg in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in healthy… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-42847922 10 milligram (mg), JNJ-42847922 20 mg and JNJ-42847922 40 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesUnited States
Study dates
8 Jun 2016to 11 Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • In Group A: For each cohort, 10 elderly non-Asian adults greater than or equal to (>=)65 years old, with at least 2 participants >=70 years and <75 years old, at least 2 participants >=75 years old, with 5 participants of each sex; In Group B: For each cohort, 10 young healthy non-Asian adults 18 to 45 years old, inclusive, matched to elderly participants in the same cohort by gender and body weight (plus [+] or minus [-]5 kilogram [kg]); In Group C: For each cohort, 10 healthy Japanese adults 20 to 60 years old, inclusive, who have resided outside of Japan for less than or equal to (<=)10 years, have parents and maternal and paternal grandparents who are Japanese, who primarily consume a Japanese diet, with 5 participants of each sex
  • Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Group B and Group C: If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of the treatment period
  • Group B and Group C: If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after the last study drug administration
  • If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Has body mass index (BMI) (weight kilogram[kg]/height^2 meter[m]^2) between 18 and 30 kg/m2 (inclusive) with a body weight not less than 50 kg for non-Asian subjects (Group A and Group B) and not less than 45 kg for Japanese subjects (Group C)

Who cannot join

  • Received a known inhibitor of cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
  • Consumption of products containing grapefruit or Seville oranges within 28 days before the first dose of the study drug is scheduled
  • Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
  • Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
  • Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Cypress, California

  • Study site

    Knoxville, Tennessee

Other trials in United States

About this study

Official title: An Open-Label Single Dose Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults

The purpose of this study is to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in healthy Japanese adults.

Conditions
Healthy
Being tested
JNJ-42847922 10 milligram (mg), JNJ-42847922 20 mg, JNJ-42847922 40 mg, JNJ-42847922 60 or 80 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-42847922 10 milligram (mg)Drug

    JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.

  • JNJ-42847922 20 mgDrug

    JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.

  • JNJ-42847922 40 mgDrug

    JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.

  • JNJ-42847922 60 or 80 mgDrug

    JNJ-42847922 will be administered as 3 or 4 tablets of 20 mg, orally, once on Day 1. Dose to be determined from Cohort 3, Period 1.

Study groups in NCT02837692
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants assigned to Cohort 1 group A (elderly non-Asian), group B (young healthy non-Asian) and group C (healthy Japanese) will receive JNJ-42847922 10 mg, 3 hours after completing dinner.
Receives: Drug: JNJ-42847922 10 milligram (mg)
Cohort 2ExperimentalParticipants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner.
Receives: Drug: JNJ-42847922 20 mg
Cohort 3ExperimentalParticipants assigned to Cohort 3 group A and group C will receive JNJ-42847922 40 mg, 3 hours after completing dinner. Participants in group B will receive JNJ-42847922 40 mg, 3 hours after completing dinner in Period 1, followed by at least 7 days washout period, further followed by JNJ-42847922 40 mg, immediately after completing dinner.
Receives: Drug: JNJ-42847922 40 mg
Cohort 4ExperimentalParticipants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner.
Receives: Drug: JNJ-42847922 60 or 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax) of JNJ-42847922

    The Cmax is the maximum observed plasma concentration.

    Measured: Day 1 (Pre-dose) up to Day 3

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

    Measured: Day 1 (Pre-dose) up to Day 3

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922

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

    Measured: Day 1 (Pre-dose) up to Day 3

Secondary outcomes (1)

  1. Number of participants with adverse events and serious adverse events as a measure of safety and tolerability

    Measured: Baseline up to 10 days after last dose of study drug (Day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study start8 Jun 2016
  3. Primary completion7 Sep 2017
  4. Study completion11 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837692
Sponsor's protocol ID
CR108176
Other IDs
42847922EDI1014
Status last verified
Oct 2017
First submitted
2 Jun 2016
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-42847922 10 milligram (mg), JNJ-42847922 20 mg and JNJ-42847922 40 mg in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of JNJ-42847922 (time frame: Day 1 (Pre-dose) up to Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02837692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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