An Open-Label Drug-Drug Interaction Study in Healthy Male Subjects to Explore the Effects of Single and Multiple Doses of JNJ-39393406 on the Pharmacokinetics of a Single Oral Dose of Midazolam

An Open-Label Drug-Drug Interaction Study in Healthy Male Subjects to Explore the Effects of Single and Multiple Doses of JNJ-39393406 on the Pharmacokinetics of a Single Oral Dose of Midazolam - JNJ-39393406 ALZ1001 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33240

Enrollment

Registered

2009-07-15

Start date

2009-07-24

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

alzheimer psychose

Interventions

The study will start with a screening. A physical examination and different standard test (ECG, blood pressure) will be performed during the screening appointment. Blood and urine samples will be ta

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Males Between 18 and 55 years of age (inclusive) BMI between 18 en 30 kg/m^2 (inclusive)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities for physical examination

Design outcomes

Primary

Measure	Time frame
The primary purpose of this investigation is to examine the effect of single and multiple doses of the new drug JNJ-39393406 (the study medication) on absorption, metabolism and excretion by the body after single administration of the drug midazolam.	—

Secondary

Measure	Time frame
The other purpose of this investigation is to examine the safety and tolerability of the new drug JNJ-39393406 (the study medication).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)