Clinical Site
Perth, Australia
Completed
NCT Number: NCT03163550
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
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
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ACHN-383
DrugOral dose
ACHN-789
DrugOral dose
Placebo
DrugOral dose
Primary outcomes
-
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Time frame: 26 days
-
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Time frame: 26 days
-
Incidence and severity of adverse events
Time frame: 26 days
-
Changes from baseline in the QTcF interval
Time frame: 19 days
Secondary outcomes
-
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Time frame: 1 day
-
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Time frame: 3 days
-
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 5 days
-
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 1 day
-
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 days
-
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time frame: 19 days
-
Urine concentrations of ACHN-789 after single dose administration
Time frame: 1 day
-
Urine concentrations of ACHN-383 after single-dose administration
Time frame: 3 days
-
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Time frame: 1 day
-
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Time frame: 5 days
-
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Time frame: 19 days
Sponsors and collaborators
Lead sponsor
Achaogen, Inc.
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- May 23, 2017
- Registry last updated
- Dec 2, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial Details
Completed
The Primary Purpose of This Study is to Determine if Biotin, Vitamin B7 is an Effective Way to Label Platelets in Survival and Recovery Studies.
NCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial Details
Completed
A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
NCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial Details
Completed
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
NCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details