A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
NCT ID: NCT03163550
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2017-05-17
2017-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
Healthy volunteers
ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Cohort 2
Healthy volunteers
ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Cohort 3
Healthy volunteers
ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Cohort 4
Healthy volunteers
ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Cohort 5
Healthy volunteers
ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Interventions
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ACHN-383
Oral dose
ACHN-789
Oral dose
Placebo
Oral dose
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Achaogen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel J Cloutier, PharmD
Role: STUDY_DIRECTOR
Achaogen, Inc.
Locations
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Clinical Site
Perth, , Australia
Countries
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Other Identifiers
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ACHN-172-001
Identifier Type: -
Identifier Source: org_study_id