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Completed

NCT Number: NCT02146742

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

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.

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Key information

Conditions

Healthy Subjects

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase

Harrow, HA1 3UJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP1707

Drug

oral

Placebo

Drug

oral

Primary outcomes

  1. Safety and tolerability measured by Adverse events (AE)

    Time frame: Day -2 to ESV (up to Day 19)

  2. Safety and tolerability measured by physical examination (PE)

    Time frame: Day -2 to ESV (up to Day 19)

  3. Safety and tolerability measured by vital signs (VS)

    Time frame: Day -2 to ESV (up to Day 19)

  4. Safety and tolerability measured by laboratory tests

    Time frame: Day -2 to ESV (up to Day 19)

  5. Safety and tolerability measured by 12 lead electrocardiogram (ECG)

    Time frame: Day -2 to ESV (up to Day 19)

Secondary outcomes

  1. PK profile of single ascending doses of ASP1707 in plasma

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 26, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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