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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 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1
Healthy volunteers
Medicin: Placebo
Oral dosis
Medicin: ACHN-383
Oral dose
Medicin: ACHN-789
Oral dose
Eksperimentel: Cohort 2
Healthy volunteers
Medicin: Placebo
Oral dosis
Medicin: ACHN-383
Oral dose
Medicin: ACHN-789
Oral dose
Eksperimentel: Cohort 3
Healthy volunteers
Medicin: Placebo
Oral dosis
Medicin: ACHN-383
Oral dose
Medicin: ACHN-789
Oral dose
Eksperimentel: Cohort 4
Healthy volunteers
Medicin: Placebo
Oral dosis
Medicin: ACHN-383
Oral dose
Medicin: ACHN-789
Oral dose
Eksperimentel: Cohort 5
Healthy volunteers
Medicin: Placebo
Oral dosis
Medicin: ACHN-383
Oral dose
Medicin: ACHN-789
Oral dose

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Achaogen, Inc.

Efterforskere

  • Studieleder: Daniel J Cloutier, PharmD, Achaogen, Inc.

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)

17. maj 2017

Primær færdiggørelse (Faktiske)

15. oktober 2017

Studieafslutning (Faktiske)

15. oktober 2017

Datoer for studieregistrering

Først indsendt

15. maj 2017

Først indsendt, der opfyldte QC-kriterier

20. maj 2017

Først opslået (Faktiske)

23. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ACHN-172-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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