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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

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

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

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