NCT01815684

Brief Summary

The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

March 19, 2013

Last Update Submit

March 19, 2013

Conditions

PharmacokineticsPharmacodynamicsHealthy SubjectsSafety

Keywords

Phase IASP3652Dose escalationMaximum Tolerated Dose (MTD)

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of single ascending doses of ASP3652 assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments

    Day -22 to ESV (7-14 days after (early) discharge)

  • Safety and tolerability of single ascending doses of ASP3652 assessed through electrocardiogram

    QT (Q wave to T wave)/QTc interval (QT interval corrected for heart rate), QT interval, RR (R wave to R wave) interval, HR (Heart Rate), PR interval, QRS interval, QTcB, QTcF

    Day -22 to ESV (7-14 days after (early) discharge)

Secondary Outcomes (3)

  • Pharmacokinetic profile of single ascending doses of ASP3652

    Days 1- 4 (Investigational period 1 - 4)

  • Effect of single ascending doses of ASP3652 on CNS Pharmacodynamics

    Days 1 - 4 (Investigational period 1 - 4)

  • Effect of single ascending doses of ASP3652 on plasma levels of enzyme substrates

    Days 1 - 4 (Investigational period 1 - 4)

Study Arms (4)

ASP3652 Group 1

EXPERIMENTAL

Dosed according to the following scheme: placebo, low dose, medium dose, high dose

Drug: ASP3652Drug: Placebo

ASP3652 Group 2

EXPERIMENTAL

Dosed according to the following scheme: low dose, placebo, medium dose, high dose

Drug: ASP3652Drug: Placebo

ASP3652 Group 3

EXPERIMENTAL

Dosed according to the following scheme: low dose, medium dose, placebo, high dose

Drug: ASP3652Drug: Placebo

ASP3652 Group 4

EXPERIMENTAL

Dosed according to the following scheme: low dose, medium dose, high dose, placebo

Drug: ASP3652Drug: Placebo

Interventions

ASP3652DRUG

Oral

ASP3652 Group 1ASP3652 Group 2ASP3652 Group 3ASP3652 Group 4
PlaceboDRUG

Oral

ASP3652 Group 1ASP3652 Group 2ASP3652 Group 3ASP3652 Group 4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 30.0kg/m2.
  • Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
  • Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy.

You may not qualify if:

  • Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only).
  • Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
  • A mean QTc(F) interval of \>430 ms (for males) and \>450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333CL, Netherlands

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: 32715381DERIVED

MeSH Terms

Interventions

ASP3652

Study Officials

  • Study Manager

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 21, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations

NL(1)