A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652

NCT ID: NCT02243657

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-05-31

Brief Summary

The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated.

The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.

Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.

For both parts of the study, the subjects stay in the clinic for one period of 18 days.

Detailed Description

This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early) discharge.

Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ASP3652 following ascending multiple oral doses. The initially planned four dose levels or matching placebo are given to four separate groups. Thereafter two additional dosage levels are further investigated. All groups receive a single dose of ASP3652 administered in the morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under fasted conditions, except the last group which receives all dosages once daily from Day 1 to Day 14.

Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple oral doses in healthy elderly male and female subjects. This part contains a single, placebo-controlled group. All subjects receive twice daily doses and administration is based on the results of Part 1.

All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests for monitoring of psychotropic effects.

Conditions

Healthy Subjects; Pharmacokinetics of ASP3652; Pharmacodynamics of ASP3652

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1: Placebo dose level

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

2: ASP3652 lowest dose level twice daily

Group Type: EXPERIMENTAL

ASP3652

Intervention Type: DRUG

oral

3:ASP3652 low dose level twice daily

Group Type: EXPERIMENTAL

ASP3652

Intervention Type: DRUG

oral

4: ASP3652 medium dose level twice daily

Group Type: EXPERIMENTAL

ASP3652

Intervention Type: DRUG

oral

5: ASP3652 high dose level twice daily

Group Type: EXPERIMENTAL

ASP3652

Intervention Type: DRUG

oral

6: ASP3652 highest dose level once daily

Group Type: EXPERIMENTAL

ASP3652

Intervention Type: DRUG

oral

Interventions

ASP3652

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.
• Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.
• Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.

Exclusion Criteria

• Pregnant or breast feeding within 6 months before screening assessment.
• Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.
• Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

PRA International

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2008-006416-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3652-CL-0002

Identifier Type: -

Identifier Source: org_study_id