A Phase I, double blind, placebo-controlled, randomized 4-way alternating cross-over study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single ascending doses of ASP3652 in healthy young Caucasian male and female subjects

A Phase I, double blind, placebo-controlled, randomized 4-way alternating cross-over study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single ascending doses of ASP3652 in healthy young Caucasian male and female subjects - Single Ascending dose study of ASP3652 in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37404

Enrollment

Registered

2012-07-24

Start date

2012-08-20

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

Chronic pelvic pain disorders Chronic abacterial pelvic pain disorders Chronic prostatitis

Interventions

A dose of ASP3652 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy young male or female subject aged 18 to 55 years inclusive. - Subject is white and of Caucasian origin. - Willing to participate and has signed the written subject informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known or suspected hypersensitivity to ASP3652, or any components of the formulation used. 2. Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for female subjects only). 3. Any of the following liver function tests (ALT, AST, γ-GT , TBL and ALP) above the upper limit of normal. In such case the assessment may be repeated once.

Design outcomes

Primary

Measure	Time frame
- Different safety parameters	—

Secondary

Measure	Time frame
- Different pharmacokinetic outcomes - Different pharmacodynamic outcomes	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)