anxiety mood disorders
Conditions
Interventions
Part 1:
The study will consist of 1 period during which the volunteer will receive
JNJ-61393215 or placebo as a single dose. JNJ-61393215 and placebo will be
given as an oral solution with 240 milli
*a randomized study*. Per group, 6 volunteers will receive
JNJ-61393215 and 2 volunteers will receive placebo. Neither the volunteer, nor
the responsible doctor knows if JNJ-61393215 or placebo will
*a double-blinded study*. However, if it is important for volunteers health,
for example in case of a serious side effect, this information can be looked up
during the study.
For safety reasons, i
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 •to investigate the PK, safety, and tolerability of JNJ 61393215 suspension (ascending dose levels) after single oral dose administration in healthy subjects under fasted conditions. Part 2 •to evaluate the relative bioavailability of a solid JNJ 61393215 capsule formulation compared to a suspension of JNJ 61393215 in healthy subjects under fasted conditions, and •to assess the effect of food (high fat/high calorie breakfast and standardized breakfast) on the PK of the solid JNJ 61393215 capsule formulation in healthy subjects. Part 3 •to investigate the PK, safety, and tolerability of JNJ 61393215 suspension (ascending dose levels) after 7 days of once daily dosing in healthy subjects under fasted conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives (Part 2 only) are to evaluate the safety and tolerability of single oral dose administration of a solid formulation of JNJ 61393215 under fed and fasted conditions. | — |
Countries
Netherlands
Outcome results
None listed