Clinical trial NCT03361540: ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
Official title: A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics
Safety
ASP8302
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety assessed by incidence of adverse events (AEs)
timeFrame: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part
measure: Safety assessed by vital signs: Body temperature
timeFrame: Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part
measure: Safety assessed by vital signs: Blood pressure
timeFrame: Up to Day 6 in SAD part Up to Day 19 in MAD part
measure: Safety assessed by vital signs: Pulse rate
timeFrame: Up to Day 6 in SAD part Up to Day 19 in MAD part
measure: Number of participants with laboratory value abnormalities and/or AEs
timeFrame: Up to Day 6 in SAD part Up to Day 19 in MAD part
measure: Safety assessed by cardiac troponin
timeFrame: Up to Day 6 in SAD part Up to Day 19 in MAD part
measure: Safety assessed by standard 12-lead electrocardiogram
timeFrame: Up to Day 6 in SAD part Up to Day 19 in MAD part
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
measure: PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
measure: PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 1 in MAD part
measure: PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma
timeFrame: Up to 72 hr after dosing in SAD part
measure: PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma
timeFrame: Day 14 in MAD part
measure: PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma
timeFrame: Day 14 in MAD part
measure: PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma
timeFrame: Day 14 in MAD part
measure: PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma
timeFrame: Day 14 in MAD part
measure: PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma
timeFrame: Up to 72 hr after dosing in SAD part
measure: PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 1 in MAD part
measure: PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
measure: PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma
timeFrame: Up to 72 hr after dosing in SAD part
measure: PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma
timeFrame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
measure: PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma
timeFrame: Up to Day 14 in MAD part
measure: PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine
timeFrame: Up to 72 hr after dosing in SAD part
measure: PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine
timeFrame: Up to 72 hr after dosing in SAD part
measure: PK parameter for ASP8302: Renal clearance (CLR) in urine
timeFrame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
measure: PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine
timeFrame: Day 14 in MAD part
measure: PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine
timeFrame: Day 14 in MAD part
measure: Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter
timeFrame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
measure: PD parameter for ASP8302: Salivary secretion
timeFrame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
Other outcomes:
Locations:
city: Toshima
country: Japan
facility: Site JP00001
state: Tokyo
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: