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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361540
• Other study ID #: 8302-CL-0101
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ASP8302
ASP8302 will be administered orally.
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
Japan	Site JP00001	Toshima	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by incidence of adverse events (AEs)	Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).	Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part
Primary	Safety assessed by vital signs: Body temperature	To assess vital signs as a criteria of safety variables.	Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part
Primary	Safety assessed by vital signs: Blood pressure	To assess vital signs as a criteria of safety variables.	Up to Day 6 in SAD part Up to Day 19 in MAD part
Primary	Safety assessed by vital signs: Pulse rate	To assess vital signs as a criteria of safety variables.	Up to Day 6 in SAD part Up to Day 19 in MAD part
Primary	Number of participants with laboratory value abnormalities and/or AEs	Number of participants with potentially clinically significant laboratory values.	Up to Day 6 in SAD part Up to Day 19 in MAD part
Primary	Safety assessed by cardiac troponin	To assess the cardiovascular system function as a criteria of safety variables.	Up to Day 6 in SAD part Up to Day 19 in MAD part
Primary	Safety assessed by standard 12-lead electrocardiogram	To assess the cardiovascular system function as a criteria of safety variables.	Up to Day 6 in SAD part Up to Day 19 in MAD part
Secondary	Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
Secondary	PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
Secondary	PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 1 in MAD part
Secondary	PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma	To assess the PK of ASP8302 in SAD part.	Up to 72 hr after dosing in SAD part
Secondary	PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma	To assess the PK of ASP8302 in SAD part.	Up to 72 hr after dosing in SAD part
Secondary	PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 1 in MAD part
Secondary	PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 14 in MAD part
Secondary	PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma	To assess the PK of ASP8302 in SAD part.	Up to 72 hr after dosing in SAD part
Secondary	PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 14 in MAD part
Secondary	PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma	To assess the PK of ASP8302 in MAD part.	Up to Day 14 in MAD part
Secondary	PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine	To assess the PK of ASP8302 in SAD part.	Up to 72 hr after dosing in SAD part
Secondary	PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine	To assess the PK of ASP8302 in SAD part.	Up to 72 hr after dosing in SAD part
Secondary	PK parameter for ASP8302: Renal clearance (CLR) in urine	To assess the PK of ASP8302 in SAD part and MAD part.	Up to 72 hr after dosing in SAD part Day 14 in MAD part
Secondary	PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine	To assess the PK of ASP8302 in MAD part.	Day 14 in MAD part
Secondary	Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter	To assess the PD of ASP8302 in SAD part and MAD part.	Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
Secondary	PD parameter for ASP8302: Salivary secretion	To assess the PD of ASP8302 in SAD part and MAD part.	Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part