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

NCT03494907 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1084592017-004770-3342847922MDD1007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in QT/QTc Intervals

  Change from baseline in QT and QTc interval will be assessed. QT interval will be measured in triplicates from 12 lead Holter extracted triplicate ECG recordings and corrected QT (QTc) interval will be calculated based on Fridericia (QTcF), Bazett (QTcB), and/or study specific power (QTcP) equations.

  Baseline up to Day 3

• Percentage of Participants with Change from Baseline in T-wave Morphology

  The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported.

  Baseline up to Day 3

• Percentage of Participants with Change from Baseline in U-wave Morphology

  The percentage of participants with change from baseline with abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported.

  Baseline up to Day 3

Secondary Outcomes (11)

• Maximum Observed Plasma Concentration (Cmax)

  Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

  Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

  Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose

• Elimination Half-Life (t1/2)

  Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose

Study Arms (4)

Seltorexant (Low and high dose)

EXPERIMENTAL

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.

Drug: Seltorexant

Moxifloxacin

EXPERIMENTAL

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.

Drug: Moxifloxacin Dose 1

Placebo Matched to Seltorexant

EXPERIMENTAL

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.

Other: Placebo Matched to Seltorexant

Placebo Matched to Moxifloxacin

EXPERIMENTAL

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.

Other: Placebo Matched to Moxifloxacin

Interventions

Seltorexant DRUG

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

Also known as: JNJ-42847922

Seltorexant (Low and high dose)

Placebo Matched to Seltorexant OTHER

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

Placebo Matched to Seltorexant

Placebo Matched to Moxifloxacin OTHER

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

Placebo Matched to Moxifloxacin

Moxifloxacin Dose 1 DRUG

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

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

seltorexant

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 11, 2018
• Study Start: April 9, 2018
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

BE (1)