A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163550
• Other study ID #: ACHN-172-001
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2017
• Last updated: November 29, 2017
• Start date: May 17, 2017
• Est. completion date: October 15, 2017

Study information

• Verified date: November 2017
• Source: Achaogen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ACHN-383
Oral dose
• ACHN-789
Oral dose
• Placebo
Oral dose

Locations

Country	Name	City	State
Australia	Clinical Site	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Achaogen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)		26 days
Primary	Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)		26 days
Primary	Incidence and severity of adverse events		26 days
Primary	Changes from baseline in the QTcF interval		19 days
Secondary	PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789		1 day
Secondary	PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383		3 days
Secondary	PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently		1 day
Secondary	PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently		5 days
Secondary	PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal		6 days
Secondary	PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal		6 days
Secondary	PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal		6 days
Secondary	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		6 days
Secondary	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		6 days
Secondary	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		6 days
Secondary	PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal		6 days
Secondary	PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal		6 days
Secondary	PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently		19 days
Secondary	Urine concentrations of ACHN-789 after single dose administration		1 day
Secondary	Urine concentrations of ACHN-383 after single-dose administration		3 days
Secondary	Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently		1 day
Secondary	Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently		5 days
Secondary	Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently		19 days