A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects

A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects - JNJ-55375515 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46723

Enrollment

Registered

2017-12-13

Start date

2018-01-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood disorders

Interventions

Part 1 Administration of the study drug JNJ-55375515 and placebo will be given as a liquid (suspension). The volume can range from 0.4 milliliters to 8 milliliters. After administration of the study

we call this *the study is blinded*. However, if it is important for the volunteers health, for example in case of a serious

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subject between 18 and 54 years of age, inclusive. Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive Non-smoker (not smoked for 3 months prior to screening)

Exclusion criteria

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 90 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.

Design outcomes

Primary

Measure	Time frame
The primary objective is to assess safety and tolerability of day-time and night-time dosing of JNJ-55375515 in healthy male subjects	—

Secondary

Measure	Time frame
The secondary objectives are to assess: - the influence of daytime dosing of JNJ-55375515 on pharmacodynamic markers including electroencephalography (EEG), heart rate variability (HRV), saccadic eye movement, body sway, sleepiness, mood, neuroendocrinology, emotional/motivational processing and simple- and complex cognition - the effect of JNJ-55375515 administered at day-time on an evoked stress response - the influence of night-time dosing of JNJ-55375515 on sleep architecture using polysomnography; - the influence of night-time dosing of JNJ-55375515 on sleepiness and performance of complex cognitive tasks; - the pharmacokinetics of single-dose morning and evening administration of JNJ-55375515 in healthy male subjects	—

Measure

Time frame

The secondary objectives are to assess: - the influence of daytime dosing of JNJ-55375515 on pharmacodynamic markers including electroencephalography (EEG), heart rate variability (HRV), saccadic eye movement, body sway, sleepiness, mood, neuroendocrinology, emotional/motivational processing and simple- and complex cognition - the effect of JNJ-55375515 administered at day-time on an evoked stress response - the influence of night-time dosing of JNJ-55375515 on sleep architecture using polysomnography; - the influence of night-time dosing of JNJ-55375515 on sleepiness and performance of complex cognitive tasks; - the pharmacokinetics of single-dose morning and evening administration of JNJ-55375515 in healthy male subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)