A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability

NCT01958047 | Completed Phase 1

• 2 other identifiers: 3652-CL-00542012-001476-11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. A further aim is to look at how the processes of metabolism, distribution and excretion of the study drug are possibly altered by the daily diet of the volunteers taking part.

Conditions

Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Effect of Race

Keywords

Phase I; ASP3652; Single dose; Dietary intake

Outcome Measures

Primary Outcomes (16)

• Pharmacokinetics of ASP3652 in plasma measured by Cmax

  maximum observed plasma concentration (Cmax)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by AUClast

  area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by AUCinf

  area under the plasma concentration-time curve from time zero extrapolated to the infinite time (AUCinf)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by tmax

  time to attain Cmax (tmax)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by tlag

  PK lag time (tlag)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by t1/2

  apparent terminal elimination half-life (t1/2)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by Vz/F

  apparent volume of terminal phase distribution at steady state (Vz/F)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by CL/F

  apparent clearance after oral administration at steady state (CL/F)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by Vz/F/kg

  body weight-adjusted apparent volume of terminal phase distribution at steady state (Vz/F/kg)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 in plasma measured by CL/F/kg

  body weight-adjusted apparent clearance after oral administration at steady state (CL/F/kg)

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by Cmax

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by AUClast

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by AUCinf

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by tmax

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by tlag

  tlag

  Day 1 to Day 4 (16 blood samples taken)

• Pharmacokinetics of ASP3652 metabolites in plasma measured by t1/2

  Day 1 to Day 4 (16 blood samples taken)

Secondary Outcomes (2)

• Plasma levels of arachidonoyl-ethanolamide (AEA, or anandamide), oleoyl-ethanolamide (OEA) and palmitoyl-ethanolamide (PEA) after a single dose of ASP3652

  Day 1 to Day 4 (12 blood samples taken)

• Safety and tolerability of a single dose of ASP3652

  Screening to ESV (at least 39 safety assessments)

Study Arms (1)

ASP3652

EXPERIMENTAL

One single dose

Drug: ASP3652

Interventions

ASP3652 DRUG

Oral

ASP3652

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a healthy male or female subject from Caucasian, Japanese, Black/African or Chinese origin. Both parents and all 4 grandparents should be of the same race.
• Subjects of Japanese or Chinese origin should be born in their respective countries and should not have lived outside of their countries for more than 5 years and 10 years, respectively.
• The subject has a Body Mass Index (BMI) in the range 18.5 - 30.0 kg/m2, inclusive (subject from Caucasian or Black/African origin) or in the range 17.5 - 29.0 kg/m2, inclusive (subject from Japanese or Chinese origin). The subject weighs at least 50 kg (subject from Caucasian or Black/African origin) or at least 45 kg (subject from Japanese or Chinese origin).

You may not qualify if:

• Female subject who is pregnant, has been pregnant within 6 months before screening, or breast feeding within 3 months before screening.
• Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
• The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the Clinical Unit.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, H1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

ASP3652

Study Officials

• Clincial Study Manager

  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: October 4, 2013
• First Posted: October 8, 2013
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

GB (1)