A Study to Investigate the Appearance and Disappearance of ASP3652 in Blood and Spinal Fluid in Healthy Male Subjects

NCT02034734 | Completed Phase 1

• 2 other identifiers: 3652-CL-00482011-004226-97
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects. Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in healthy young Caucasian male subjects and to assess the safety and tolerability of multiple doses of ASP3652 in healthy young Caucasian male subjects.

Conditions

Pharmacokinetics of ASP3652; Pharmacodynamics of ASP3652; Healthy Subjects

Keywords

Phase 1; ASP3652; Cerebrospinal fluid (CSF); Multiple doses

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (PK) of ASP3652 in plasma measured by area under the plasma concentration-time curve in the dosing interval (AUCtau)

  Days 5, 7 and 9, and Days 10 - 12

• PK of ASP3652 in plasma measured by maximum observed plasma concentration (Cmax)

  Days 5, 7 and 9, and Days 10 - 12

• PK parameter of ASP3652 in cerebrospinal fluid (CSF) measured by area under the plasma concentration-time curve in the dosing interval (AUCtau)

  Days 10 -11

• PK parameter of ASP3652 in cerebrospinal fluid (CSF) measured by maximum observed plasma concentration (Cmax)

  Days 10 -11

Secondary Outcomes (3)

• Additional PK of multiple doses of ASP3652 in plasma and cerebrospinal fluid (CSF)

  Plasma: Days 5, 7 and 9, and Days 10 - 12 / CSF: Days 10 -11

• Pharmacodynamics (PD) of multiple doses of ASP3652 in plasma and CSF

  Plasma: Days 1-3 and Days 5-12 / CSF: Days 1-2 and Days 10-11

• Safety and tolerability of multiple doses of ASP3652

  Screening (Day -22 to Day -2) to End-of-Study Visit (7 to 14 days after (early) discharge)

Study Arms (1)

1: ASP3652

EXPERIMENTAL

Multiple doses of ASP3652

Drug: ASP3652

Interventions

ASP3652 DRUG

oral

1: ASP3652

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is white and of Caucasian origin.
• Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
• Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.

You may not qualify if:

• Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
• History of excessive bleeding or bruising.
• Abnormalities of coagulation screen including platelet count, prothrombin time (PT) and activated partial thromboplastin time (aPTT).

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

PAREXEL Early Phase Clinical Unit

Harrow, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• Takizawa M, Cerneus D, Michon I, Rijnders S, Meijer J, Someya A, Sato Y. Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels. Adv Ther. 2020 Sep;37(9):3967-3984. doi: 10.1007/s12325-020-01451-6. Epub 2020 Jul 26.

  PMID: 32715381 DERIVED

MeSH Terms

Interventions

ASP3652

Study Officials

• Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 13, 2014
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

GB (1)