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Completed

NCT Number: NCT01815684

A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333CL, Netherlands

About this study

Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and females.

The washout period between dosing occasions is at least 7 days. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments.

On Day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks.

The subjects are discharged on Day 4 of each investigational period. The End of Study Visit (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of investigational period 4.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ASP3652

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

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

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

  2. Safety and tolerability of single ascending doses of ASP3652 assessed through electrocardiogram

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

    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

Secondary outcomes

  1. Pharmacokinetic profile of single ascending doses of ASP3652

    Time frame: Days 1- 4 (Investigational period 1 - 4)

    Plasma: Cmax (Maximum concentration), AUClast (AUC until last sample taken), AUCinf (AUC extrapolated until infinity), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance)/ Urine: Aelast (Amount excreted in urine until last sample), Aeinf (Cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose), Aelast% (Percentage of unchanged drug excreted into the urine from time of last measurable concentration), Aeinf% (Percentage of unchanged drug excreted into the urine from time zero to infinity after single dose), CLR (Renal clearance)

  2. Effect of single ascending doses of ASP3652 on CNS Pharmacodynamics

    Time frame: Days 1 - 4 (Investigational period 1 - 4)

    Body sway, alertness, perception, mood, learning, memory, distraction, adaptive tracking, eye movements, addiction, neuro-endocrine parameters

  3. Effect of single ascending doses of ASP3652 on plasma levels of enzyme substrates

    Time frame: Days 1 - 4 (Investigational period 1 - 4)

    Rmax, tmax R, AUR

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

A Phase I, Double Blind, Placebo-controlled, Randomized 4-way Alternating Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Ascending Doses of ASP3652 in Healthy Young Caucasian Male and Female Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 21, 2013
Registry last updated
Mar 21, 2013

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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