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

Completed

• Conditions: Chronic pelvic pain disorders; Chronic abacterial pelvic pain disorders; Chronic prostatitis

• Registration Number: NL-OMON37404
• Lead Sponsor: Astellas Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Different safety parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Different pharmacokinetic outcomes<br /><br><br /><br>- Different pharmacodynamic outcomes</p><br>