A Multi-cohort, Randomized Study in Healthy Subjects to Assess the Pharmacokinetics and Safety of Single and Multiple Ascending Doses of JNJ-61393215 (Suspension), and to Assess the Relative Bioavailability, and the Effect of Food on the Pharmacokinetics, of a New Solid Formulation (Capsules) of JNJ-61393215

Completed

• Conditions: anxiety; mood disorders; 10002861

• Registration Number: NL-OMON46054
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-04-16
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

-Healthy male or female subjects
-18-55 yrs, inclusive at screening
-BMI: 18.0-30.0 kg/m2, inclusive at screening
-Weight not less than 50 kg at screening
-Non-smoking
-Female of non-childbearing potential
-Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1<br /><br>•to investigate the PK, safety, and tolerability of JNJ 61393215 suspension<br /><br>(ascending dose levels) after single oral dose administration in healthy<br /><br>subjects under fasted conditions.<br /><br><br /><br>Part 2<br /><br>•to evaluate the relative bioavailability of a solid JNJ 61393215 capsule<br /><br>formulation compared to a suspension of JNJ 61393215 in healthy subjects under<br /><br>fasted conditions, and<br /><br>•to assess the effect of food (high fat/high calorie breakfast and standardized<br /><br>breakfast) on the PK of the solid JNJ 61393215 capsule formulation in healthy<br /><br>subjects.<br /><br><br /><br>Part 3<br /><br>•to investigate the PK, safety, and tolerability of JNJ 61393215 suspension<br /><br>(ascending dose levels) after 7 days of once daily dosing in healthy subjects<br /><br>under fasted conditions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives (Part 2 only) are to evaluate the safety and<br /><br>tolerability of single oral dose administration of a solid formulation of JNJ<br /><br>61393215 under fed and fasted conditions.</p><br>