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Completed

NCT Number: NCT03361540

ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects

The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.

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Key information

Conditions

Healthy Subjects

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Toshima City, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
  • Body-mass index (BMI) at screening: ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].

Exclusion criteria

  • Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
  • Subjects who conducted or is scheduled to conduct any of the blood donation or blood drawing in designated period before Day -2
  • Subject who received or is scheduled to receive any medications within seven days before the hospital admission.
  • Any deviation from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or on the day of hospital admission (Day -1).
  • Subject who meets any of the criteria for laboratory tests at screening or on the day of hospital admission (Day -2).
  • Any deviation from the normal range of routine 12-lead electrocardiogram at screening.
  • Subjects with a complication or history of drug allergies.
  • Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission.
  • Subjects with a complication or history of hepatic disease.
  • Subjects with a complication or history of cardiac disease.
  • Subjects with a complication or history of respiratory disease except for history of asthma in childhood.
  • Subjects with a complication or history of gastrointestinal disease except for a history of appendicitis.
  • Subjects with a history of gastrointestinal resection except for appendicitis.
  • Subjects with a complication or history of renal disease except for a history of calculus.
  • Subjects with a complication or history of endocrine disease.
  • Subjects with a complication or history of cerebrovascular disease.
  • Subjects with a complication or history of malignant tumor.
  • Subjects who received ASP8302 previously.
  • Subjects who have a habit of excessive smoking or drinking alcohol.

Treatment and study plan

ASP8302

Drug

ASP8302 will be administered orally.

Placebo

Drug

Placebo will be administered orally.

Primary outcomes

  1. Safety assessed by incidence of adverse events (AEs)

    Time frame: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part

    Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

  2. Safety assessed by vital signs: Body temperature

    Time frame: Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part

    To assess vital signs as a criteria of safety variables.

  3. Safety assessed by vital signs: Blood pressure

    Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part

    To assess vital signs as a criteria of safety variables.

  4. Safety assessed by vital signs: Pulse rate

    Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part

    To assess vital signs as a criteria of safety variables.

  5. Number of participants with laboratory value abnormalities and/or AEs

    Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part

    Number of participants with potentially clinically significant laboratory values.

  6. Safety assessed by cardiac troponin

    Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part

    To assess the cardiovascular system function as a criteria of safety variables.

  7. Safety assessed by standard 12-lead electrocardiogram

    Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part

    To assess the cardiovascular system function as a criteria of safety variables.

Secondary outcomes

  1. Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  2. PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  3. PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 1 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  4. PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma

    Time frame: Up to 72 hr after dosing in SAD part

    To assess the PK of ASP8302 in SAD part.

  5. PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  6. PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  7. PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  8. PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  9. PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma

    Time frame: Up to 72 hr after dosing in SAD part

    To assess the PK of ASP8302 in SAD part.

  10. PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 1 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  11. PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  12. PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma

    Time frame: Up to 72 hr after dosing in SAD part

    To assess the PK of ASP8302 in SAD part.

  13. PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma

    Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  14. PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma

    Time frame: Up to Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  15. PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine

    Time frame: Up to 72 hr after dosing in SAD part

    To assess the PK of ASP8302 in SAD part.

  16. PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine

    Time frame: Up to 72 hr after dosing in SAD part

    To assess the PK of ASP8302 in SAD part.

  17. PK parameter for ASP8302: Renal clearance (CLR) in urine

    Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part

    To assess the PK of ASP8302 in SAD part and MAD part.

  18. PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  19. PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine

    Time frame: Day 14 in MAD part

    To assess the PK of ASP8302 in MAD part.

  20. Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter

    Time frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part

    To assess the PD of ASP8302 in SAD part and MAD part.

  21. PD parameter for ASP8302: Salivary secretion

    Time frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part

    To assess the PD of ASP8302 in SAD part and MAD part.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Oct 21, 2024

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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