A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants

NCT ID: NCT03494907

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2018-08-13

Brief Summary

The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Seltorexant (Low and high dose)

Participants will receive seltorexant tablets orally in 2 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.

Group Type: EXPERIMENTAL

Seltorexant

Intervention Type: DRUG

Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1.

Moxifloxacin

Participants will receive moxifloxacin tablets orally in 1 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.

Group Type: EXPERIMENTAL

Moxifloxacin Dose 1

Intervention Type: DRUG

Participants will be administered oral dose 1 of moxifloxacin on Day 1.

Placebo Matched to Seltorexant

Participants will receive seltorexant placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.

Group Type: EXPERIMENTAL

Placebo Matched to Seltorexant

Intervention Type: OTHER

Participants will be administered matching placebo to seltorexant tablets on Day 1.

Placebo Matched to Moxifloxacin

Participants will receive moxifloxacin placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.

Group Type: EXPERIMENTAL

Placebo Matched to Moxifloxacin

Intervention Type: OTHER

Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1.

Interventions

Seltorexant

Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1.

Intervention Type: DRUG

Placebo Matched to Seltorexant

Participants will be administered matching placebo to seltorexant tablets on Day 1.

Intervention Type: OTHER

Placebo Matched to Moxifloxacin

Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1.

Intervention Type: OTHER

Moxifloxacin Dose 1

Participants will be administered oral dose 1 of moxifloxacin on Day 1.

Intervention Type: DRUG

Other Intervention Names

JNJ-42847922

Eligibility Criteria

Inclusion Criteria

• Have signed informed consent form (ICF) indicating they understand the purpose of and procedures required for the study, including the required pharmacogenomic component (which specifies testing of genes predisposing to long or short QT and related cardiac syndromes), and are willing to participate in the study. Consent for sample storage will be obtained in the ICF
• Be Willing to adhere to the prohibitions and restrictions specified in the protocol
• A female participant must be either not of childbearing potential (ie, postmenopausal, permanently sterile) or of childbearing potential and practicing a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly)
• A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
• A male participant, 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
• Must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Heart rate between 45 and 100 beats per minute (bpm), inclusive

Exclusion Criteria

• Clinically significant abnormal values for hematology, serum chemistry (including thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at admission to the study site
• Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study site as deemed appropriate by the investigator
• Received a known inhibitor of CYP3A4 or CYP2C9 activity within 14 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
• Known allergy to the study drug or any of the excipients of the formulation
• 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
• A woman who is pregnant, breast-feeding, or planning to become pregnant during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2017-004770-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

42847922MDD1007

Identifier Type: OTHER

Identifier Source: secondary_id

CR108459

Identifier Type: -

Identifier Source: org_study_id