NCT03723746|CompletedPhase 1

A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study to Assess the Safety and Tolerability of JNJ-67670187 in Healthy Participants

Janssen Research & Development, LLC ClinicalTrials.gov

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3 other identifiers

CR1085322018-002287-8167670187IBD1001

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredOct 2018

StartedOct 2018

CompletionDec 2019

Brief Summary

The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 healthy

Timeline

Completed

Started Oct 2018

Longer than P75 for phase_1 healthy

Geographic Reach

2 countries

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

October 25, 2018

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed

Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

October 26, 2018

Last Update Submit

February 18, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

Part 1 Single Day (SD) Dose: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
3 Months post final dose or up to Day 84
Part 2 Multiple Day (MD) Dose : Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 98 that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
3 Months post final dose or up to Day 98
Part 1 SD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability
Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
Predose up to Day 84
Part 2 MD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability
Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
Predose up to Day 98

Secondary Outcomes (1)

Detection and Abundance of JNJ-67670187
Pre-dose, up to Day 82 (SD) and up to Day 98 (MD)

Study Arms (9)

Cohort 1: Dose 1 or Placebo (Part 1 - SD)

EXPERIMENTAL

Participants will receive a single oral dose (single day \[SD\] Dose 1) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1.