NCT03163550

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

May 15, 2017

Last Update Submit

November 29, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

  • Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)

    26 days

  • Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)

    26 days

  • Incidence and severity of adverse events

    26 days

  • Changes from baseline in the QTcF interval

    19 days

Secondary Outcomes (54)

  • PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789

    1 day

  • PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383

    3 days

  • PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789

    1 day

  • PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383

    3 days

  • PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789

    1 day

  • +49 more secondary outcomes

Study Arms (5)

Cohort 1

EXPERIMENTAL

Healthy volunteers

Drug: ACHN-383Drug: ACHN-789Drug: Placebo

Cohort 2

EXPERIMENTAL

Healthy volunteers

Drug: ACHN-383Drug: ACHN-789Drug: Placebo

Cohort 3

EXPERIMENTAL

Healthy volunteers

Drug: ACHN-383Drug: ACHN-789Drug: Placebo

Cohort 4

EXPERIMENTAL

Healthy volunteers

Drug: ACHN-383Drug: ACHN-789Drug: Placebo

Cohort 5

EXPERIMENTAL

Healthy volunteers

Drug: ACHN-383Drug: ACHN-789Drug: Placebo

Interventions

ACHN-383DRUG

Oral dose

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
ACHN-789DRUG

Oral dose

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

Oral dose

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site

Perth, Australia

Location

Study Officials

  • Daniel J Cloutier, PharmD

    Achaogen, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

May 17, 2017

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

AU(1)