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A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects

Sponsor
Astellas Pharma Europe B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02146742
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
2
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The first group receives the lowest dose while the last group receives the highest dose. ASP1707 or matching placebo is administered as a single dose under fasted conditions.

Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1 and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.

Escalation to the next higher dose takes place after review of the safety and tolerability data from the previous dose.

Safety assessments are performed throughout the study. Plasma and urine samples are collected for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD) analysis.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Double Blind, Randomized and Placebo Controlled Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ASP1707 in Healthy Young Japanese Male Subjects
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1. ASP1707 lowest dose

Drug: ASP1707
oral

Drug: Placebo
oral
Experimental: 2 ASP1707 higher dose

Drug: ASP1707
oral

Drug: Placebo
oral
Experimental: 3. ASP1707 Highest dose

Drug: ASP1707
oral

Drug: Placebo
oral

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability measured by Adverse events (AE) [Day -2 to ESV (up to Day 19)]

  2. Safety and tolerability measured by physical examination (PE) [Day -2 to ESV (up to Day 19)]

  3. Safety and tolerability measured by vital signs (VS) [Day -2 to ESV (up to Day 19)]

  4. Safety and tolerability measured by laboratory tests [Day -2 to ESV (up to Day 19)]

  5. Safety and tolerability measured by 12 lead electrocardiogram (ECG) [Day -2 to ESV (up to Day 19)]

Secondary Outcome Measures

  1. PK profile of single ascending doses of ASP1707 in plasma [Days 1 to 5]

    area under the plasma concentration - time curve (AUC) extrapolated to time = infinity (AUCinf), AUC from time of dosing until last measurable concentration (AUClast), time to reach quantifiable concentrations (tlag), maximum concentration (Cmax), time to attain Cmax (tmax), terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent clearance (CL/F)

  2. PK profile of single ascending doses of ASP1707 in urine [Days 1 to 5]

    amount excreted unchanged into urine (Ae) from time of dosing until last measurable concentration (Aelast), Ae extrapolated to time = infinity (Aeinf), Ae from time of dosing until last measurable concentration as percentage of total dose (Aelast%), Ae extrapolated to time = infinity as percentage of total dose (Aeinf%), renal clearance (CLR)

  3. Pharmacodynamics of Testosterone (T) [Day -1 to ESV]

    measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose

  4. Pharmacodynamics of Luteinizing Hormone (LH) [Day -1 to ESV]

    measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose

  5. Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels [Day -1 to ESV]

    measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Born in Japan

  • Both parents are of Japanese descent

  • Time residing outside Japan does not exceed 5 years

  • Maintains Japanese life style including diet

  • Male subject must be non-fertile, i.e. surgically sterilized or must practice an effective contraceptive method

Exclusion Criteria:

  • Subjects with out-of-range T levels in serum at screening

  • Subjects with any history of cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel Early Phase Harrow United Kingdom HA1 3UJ

Sponsors and Collaborators

  • Astellas Pharma Europe B.V.

Investigators

  • Study Chair: Clinical Study Manager, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier:
NCT02146742
Other Study ID Numbers:
  • 1707-CL-0002
  • 2010-024040-15
First Posted:
May 26, 2014
Last Update Posted:
May 26, 2014
Last Verified:
May 1, 2014
Keywords provided by Astellas Pharma Europe B.V.
ASP1707
Japanese subjects
Safety
Pharmacokinetics
Pharmacodynamics

Study Results

No Results Posted as of May 26, 2014