- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03958864
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.
The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Glendale, California, Forenede Stater, 91206
- Paraxel International
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Subjects must satisfy all of the following criteria to be enrolled in the study:
- Healthy, adult, male and female subjects.
- Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
- Caucasian subjects who have age and body mass index matched with Japanese subjects.
Exclusion Criteria:
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
- Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
- Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CC-90001 100 mg
100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
Eksperimentel: CC-90001 200 mg
200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
Eksperimentel: CC-90001 400 mg
400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pharmacokinetic- AUC0-t
Tidsramme: Day 1 and Day 7- 10
|
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
|
Day 1 and Day 7- 10
|
Pharmacokinetic- AUC0-∞
Tidsramme: Day 1 and Day 7- 10
|
Area under the plasma concentration-time curve from time zero to infinity
|
Day 1 and Day 7- 10
|
Pharmacokinetic- CL/F
Tidsramme: Day 1 and Day 7- 10
|
Estimation of apparent clearance of drug from plasma after extravascular administration
|
Day 1 and Day 7- 10
|
Pharmacokinetic- Vz/F
Tidsramme: Day 1 and Day 7- 10
|
Estimation of apparent volume of distribution during the terminal phase
|
Day 1 and Day 7- 10
|
Pharmacokinetic- Cmax
Tidsramme: Day 1 and Day 7
|
Estimation of observed maximum plasma concentration
|
Day 1 and Day 7
|
Pharmacokinetic- Tmax
Tidsramme: Day 1 and Day 7
|
Estimation of time to Cmax
|
Day 1 and Day 7
|
Pharmacokinetic- t1/2
Tidsramme: Day 1 and Day 7- 10
|
Description: Estimation of terminal elimination half-life
|
Day 1 and Day 7- 10
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Adverse Events (AEs)
Tidsramme: From enrollment until at least 28 days after completion of study treatment
|
Number participants with Adverse Event
|
From enrollment until at least 28 days after completion of study treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CC-90001-CP-006
- U1111-1229-5813
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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