- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03183739
Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects
30. september 2018 opdateret af: Astellas Pharma Inc
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tokyo
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Sumida, Tokyo, Japan
- Site JP00001
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 44 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: ASP8062 lower dose
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.
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ASP8062 will be administered orally.
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Eksperimentel: ASP8062 middle dose
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.
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ASP8062 will be administered orally.
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Eksperimentel: ASP8062 higher dose
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.
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ASP8062 will be administered orally.
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Placebo komparator: Placebo
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.
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Placebo vil blive indgivet oralt.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety assessed by incidence of adverse events
Tidsramme: Up to Day 38
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Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
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Up to Day 38
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Safety assessed by vital signs: supine blood pressure
Tidsramme: Up to Day 38
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To assess the vital sign as a criteria of safety and tolerability variables.
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Up to Day 38
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Safety assessed by vital signs: supine pulse rate
Tidsramme: Up to Day 38
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To assess the vital sign as a criteria of safety and tolerability variables.
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Up to Day 38
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Safety assessed by vital signs: axillary body temperature
Tidsramme: Up to Day 38
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To assess the vital sign as a criteria of safety and tolerability variables.
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Up to Day 38
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Orthostatic challenge tests
Tidsramme: Up to Day 20
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To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
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Up to Day 20
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Safety assessed by laboratory tests: Hematology
Tidsramme: Up to Day 38
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To assess hematology as a criteria of safety and tolerability variables.
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Up to Day 38
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Safety assessed by laboratory tests: Biochemistry
Tidsramme: Up to Day 38
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To assess biochemistry as a criteria of safety and tolerability variables.
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Up to Day 38
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Safety assessed by laboratory tests: Urinalysis
Tidsramme: Up to Day 38
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To assess urinalysis as a criteria of safety and tolerability variables.
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Up to Day 38
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Safety assessed by 12-lead electrocardiogram
Tidsramme: Up to Day 21
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To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
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Up to Day 21
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Columbia-Suicide Severity Rating Scale
Tidsramme: Up to Day 20
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To assess the suicide risk
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Up to Day 20
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Safety assessed by body weight
Tidsramme: Up to Day 38
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To assess the body weight as a criteria of safety and tolerability variables.
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Up to Day 38
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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PK parameter for ASP8062: Time to maximum concentration (Tmax)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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PK parameter for ASP8062: Terminal elimination half-life (t1/2)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part.
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Up to Day 6
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PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part.
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Up to Day 6
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PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part.
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Up to Day 6
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PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part.
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Up to Day 6
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PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part.
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Up to Day 6
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PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Tidsramme: From Day 7 to Day 38
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To assess the PK of ASP8062 in multiple dose part.
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From Day 7 to Day 38
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PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Tidsramme: From Day 7 to Day 20
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To assess the PK of ASP8062 in multiple dose part.
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From Day 7 to Day 20
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PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
Tidsramme: Up to Day 6
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To assess the PK of ASP8062 in single dose part
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Up to Day 6
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PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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PK parameter for ASP8062: Time of the last measurable concentration (tlast)
Tidsramme: Up to Day 38
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To assess the PK of ASP8062 in single dose part and multiple dose part.
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Up to Day 38
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Accumulation Ratio (Rac) of Cmax
Tidsramme: From Day 7 to Day 38
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To assess the PK of ASP8062 in multiple dose part.
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From Day 7 to Day 38
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Rac of AUC
Tidsramme: From Day 7 to Day 38
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To assess the PK of ASP8062 in multiple dose part.
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From Day 7 to Day 38
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Peak-Trough Ratio for last dosing in multiple dose part
Tidsramme: Day 20 and Day 21
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To assess the PK of ASP8062 in multiple dose part.
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Day 20 and Day 21
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juni 2017
Primær færdiggørelse (Faktiske)
6. oktober 2017
Studieafslutning (Faktiske)
6. oktober 2017
Datoer for studieregistrering
Først indsendt
9. juni 2017
Først indsendt, der opfyldte QC-kriterier
9. juni 2017
Først opslået (Faktiske)
12. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. september 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8062-CL-0004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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Kliniske forsøg med ASP8062
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Astellas Pharma Global Development, Inc.AfsluttetSunde frivilligeForenede Stater
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Astellas Pharma Global Development, Inc.Trukket tilbage
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Astellas Pharma Global Development, Inc.National Institute on Drug Abuse (NIDA)Afsluttet
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Astellas Pharma Global Development, Inc.AfsluttetFibromyalgiForenede Stater
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National Institute on Alcohol Abuse and Alcoholism...Astellas Pharma IncAfsluttetAlkohol drikke | Alkoholbrugsforstyrrelse | Alkoholforbrugsforstyrrelse (AUD)Forenede Stater