Clinical trial NCT03183739: Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects
Official title: ASP8062 Phase 1 Study - 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 Volunteers
Keywords: ASP8062
Pharmacokinetics
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly 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/m\^2 and \< 26.4 kg/m\^2 \[BMI = Body weight (kg) ÷ {Body height (m)\^2}\].
* Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
* Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
* Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
* Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.

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 received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission.
* Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1).
* Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
* Any deviation from the normal range of routine 12-lead ECG at screening.
* Subjects with a complication or history of drug allergies.
* Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
* Subjects with a history of gastrointestinal resection except for appendicitis.
* Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
* Subjects who received ASP8062 previously.
* Subject has a relevant history of suicide attempt or suicidal behavior.

Primary outcomes:
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Day 38
measure: Safety assessed by vital signs: supine blood pressure
timeFrame: Up to Day 38
measure: Safety assessed by vital signs: supine pulse rate
timeFrame: Up to Day 38
measure: Safety assessed by vital signs: axillary body temperature
timeFrame: Up to Day 38
measure: Orthostatic challenge tests
timeFrame: Up to Day 20
measure: Safety assessed by laboratory tests: Hematology
timeFrame: Up to Day 38
measure: Safety assessed by laboratory tests: Biochemistry
timeFrame: Up to Day 38
measure: Safety assessed by laboratory tests: Urinalysis
timeFrame: Up to Day 38
measure: Safety assessed by 12-lead electrocardiogram
timeFrame: Up to Day 21
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Up to Day 20
measure: Safety assessed by body weight
timeFrame: Up to Day 38
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
timeFrame: Up to Day 38
measure: PK parameter for ASP8062: Time to maximum concentration (Tmax)
timeFrame: Up to Day 38
measure: PK parameter for ASP8062: Terminal elimination half-life (t1/2)
timeFrame: Up to Day 38
measure: PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
timeFrame: Up to Day 38
measure: PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
timeFrame: From Day 7 to Day 38
measure: PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
timeFrame: From Day 7 to Day 20
measure: PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
timeFrame: Up to Day 6
measure: PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
timeFrame: Up to Day 38
measure: PK parameter for ASP8062: Time of the last measurable concentration (tlast)
timeFrame: Up to Day 38
measure: Accumulation Ratio (Rac) of Cmax
timeFrame: From Day 7 to Day 38
measure: Rac of AUC
timeFrame: From Day 7 to Day 38
measure: Peak-Trough Ratio for last dosing in multiple dose part
timeFrame: Day 20 and Day 21
Other outcomes:
Locations:
city: Sumida
country: Japan
facility: Site JP00001
state: Tokyo
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: