- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03163550
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
29. november 2017 oppdatert av: Achaogen, Inc.
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Perth, Australia
- Clinical Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria:
- Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
- Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
- Body mass index (BMI) of ≥19 kg/m^2 to ≤32 kg/m^2 and weight ≥50 kg to ≤125 kg
- Normal renal function as determined by creatinine clearance (CLcr) rate
Key Exclusion Criteria:
- Pregnant women
- History of any hepatic or biliary disorder or disease
- Any condition that could possibly affect oral drug absorption
- Unstable cardiovascular disease
- Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- HIV positive
- Active malignancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 1
Healthy volunteers
|
Oral dose
Oral dose
Oral dose
|
Eksperimentell: Cohort 2
Healthy volunteers
|
Oral dose
Oral dose
Oral dose
|
Eksperimentell: Cohort 3
Healthy volunteers
|
Oral dose
Oral dose
Oral dose
|
Eksperimentell: Cohort 4
Healthy volunteers
|
Oral dose
Oral dose
Oral dose
|
Eksperimentell: Cohort 5
Healthy volunteers
|
Oral dose
Oral dose
Oral dose
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Tidsramme: 26 days
|
26 days
|
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Tidsramme: 26 days
|
26 days
|
Incidence and severity of adverse events
Tidsramme: 26 days
|
26 days
|
Changes from baseline in the QTcF interval
Tidsramme: 19 days
|
19 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Tidsramme: 1 day
|
1 day
|
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Tidsramme: 3 days
|
3 days
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 1 day
|
1 day
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 5 days
|
5 days
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Tidsramme: 6 days
|
6 days
|
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Tidsramme: 19 days
|
19 days
|
Urine concentrations of ACHN-789 after single dose administration
Tidsramme: 1 day
|
1 day
|
Urine concentrations of ACHN-383 after single-dose administration
Tidsramme: 3 days
|
3 days
|
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Tidsramme: 1 day
|
1 day
|
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Tidsramme: 5 days
|
5 days
|
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Tidsramme: 19 days
|
19 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Daniel J Cloutier, PharmD, Achaogen, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. mai 2017
Primær fullføring (Faktiske)
15. oktober 2017
Studiet fullført (Faktiske)
15. oktober 2017
Datoer for studieregistrering
Først innsendt
15. mai 2017
Først innsendt som oppfylte QC-kriteriene
20. mai 2017
Først lagt ut (Faktiske)
23. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ACHN-172-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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