Healthy VolunteersPhase 1NCT03183739
Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects
A Phase 1 study testing ASP8062 in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASP8062
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jun 2017to 6 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 -
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.
- Conditions
- Healthy Volunteers
- Being tested
- ASP8062, Placebo
- Keywords
- ASP8062, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8062Drug
ASP8062 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| ASP8062 lower dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. Receives: Drug: ASP8062 |
| ASP8062 middle dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. Receives: Drug: ASP8062 |
| ASP8062 higher dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. Receives: Drug: ASP8062 |
| Placebo | Placebo comparator | Subjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of adverse events
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to Day 38
Safety assessed by vital signs: supine blood pressure
To assess the vital sign as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Safety assessed by vital signs: supine pulse rate
To assess the vital sign as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Safety assessed by vital signs: axillary body temperature
To assess the vital sign as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Orthostatic challenge tests
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Measured: Up to Day 20
Safety assessed by laboratory tests: Hematology
To assess hematology as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Safety assessed by laboratory tests: Biochemistry
To assess biochemistry as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Safety assessed by laboratory tests: Urinalysis
To assess urinalysis as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Safety assessed by 12-lead electrocardiogram
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Measured: Up to Day 21
Columbia-Suicide Severity Rating Scale
To assess the suicide risk
Measured: Up to Day 20
Safety assessed by body weight
To assess the body weight as a criteria of safety and tolerability variables.
Measured: Up to Day 38
Secondary outcomes (17)
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
PK parameter for ASP8062: Time to maximum concentration (Tmax)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
PK parameter for ASP8062: Terminal elimination half-life (t1/2)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
To assess the PK of ASP8062 in single dose part.
Measured: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
To assess the PK of ASP8062 in single dose part.
Measured: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
To assess the PK of ASP8062 in single dose part.
Measured: Up to Day 6
PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
To assess the PK of ASP8062 in single dose part.
Measured: Up to Day 6
PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
To assess the PK of ASP8062 in single dose part.
Measured: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
To assess the PK of ASP8062 in multiple dose part.
Measured: From Day 7 to Day 38
PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
To assess the PK of ASP8062 in multiple dose part.
Measured: From Day 7 to Day 20
PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
To assess the PK of ASP8062 in single dose part
Measured: Up to Day 6
PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
PK parameter for ASP8062: Time of the last measurable concentration (tlast)
To assess the PK of ASP8062 in single dose part and multiple dose part.
Measured: Up to Day 38
Accumulation Ratio (Rac) of Cmax
To assess the PK of ASP8062 in multiple dose part.
Measured: From Day 7 to Day 38
Rac of AUC
To assess the PK of ASP8062 in multiple dose part.
Measured: From Day 7 to Day 38
Peak-Trough Ratio for last dosing in multiple dose part
To assess the PK of ASP8062 in multiple dose part.
Measured: Day 20 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start20 Jun 2017
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183739
- Sponsor's protocol ID
- 8062-CL-0004
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2017
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT03183739
- Acronym / sponsor ID
- 8062-CL-0004
- Conditions
- Healthy Volunteers
- Keywords
- ASP8062, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP8062 lower dose | Experimental | Drug: ASP8062Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
| ASP8062 middle dose | Experimental | Drug: ASP8062Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
| ASP8062 higher dose | Experimental | Drug: ASP8062Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8062ASP8062 will be administered orally. | Drug | ASP8062 higher dose, ASP8062 lower dose, ASP8062 middle dose |
| PlaceboPlacebo will be administered orally. | Drug | Placebo |
Primary outcome
Safety assessed by incidence of adverse events
Time frame: Up to Day 38
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Safety assessed by vital signs: supine blood pressure
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Safety assessed by vital signs: supine pulse rate
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Safety assessed by vital signs: axillary body temperature
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Orthostatic challenge tests
Time frame: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Safety assessed by laboratory tests: Hematology
Time frame: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Safety assessed by laboratory tests: Biochemistry
Time frame: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Safety assessed by laboratory tests: Urinalysis
Time frame: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Safety assessed by 12-lead electrocardiogram
Time frame: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Columbia-Suicide Severity Rating Scale
Time frame: Up to Day 20
To assess the suicide risk
Safety assessed by body weight
Time frame: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
17 secondary outcomes
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
Time frame: Up to Day 38
PK parameter for ASP8062: Time to maximum concentration (Tmax)
Time frame: Up to Day 38
PK parameter for ASP8062: Terminal elimination half-life (t1/2)
Time frame: Up to Day 38
PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Time frame: Up to Day 38
PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
Time frame: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to Day 6
PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
Time frame: Up to Day 6
PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
Time frame: Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: From Day 7 to Day 38
PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: From Day 7 to Day 20
PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
Time frame: Up to Day 6
PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
Time frame: Up to Day 38
PK parameter for ASP8062: Time of the last measurable concentration (tlast)
Time frame: Up to Day 38
Accumulation Ratio (Rac) of Cmax
Time frame: From Day 7 to Day 38
Rac of AUC
Time frame: From Day 7 to Day 38
Peak-Trough Ratio for last dosing in multiple dose part
Time frame: Day 20 and Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP8062 in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by incidence of adverse events (time frame: Up to Day 38). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.