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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03163550




Registration number
NCT03163550
Ethics application status
Date submitted
15/05/2017
Date registered
23/05/2017
Date last updated
2/12/2017

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
Scientific 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
Secondary ID [1] 0 0
ACHN-172-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACHN-383
Treatment: Drugs - ACHN-789
Treatment: Drugs - Placebo

Experimental: Cohort 1 - Healthy volunteers

Experimental: Cohort 2 - Healthy volunteers

Experimental: Cohort 3 - Healthy volunteers

Experimental: Cohort 4 - Healthy volunteers

Experimental: Cohort 5 - Healthy volunteers


Treatment: Drugs: ACHN-383
Oral dose

Treatment: Drugs: ACHN-789
Oral dose

Treatment: Drugs: Placebo
Oral dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Timepoint [1] 0 0
26 days
Primary outcome [2] 0 0
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Timepoint [2] 0 0
26 days
Primary outcome [3] 0 0
Incidence and severity of adverse events
Timepoint [3] 0 0
26 days
Primary outcome [4] 0 0
Changes from baseline in the QTcF interval
Timepoint [4] 0 0
19 days
Secondary outcome [1] 0 0
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Timepoint [2] 0 0
3 days
Secondary outcome [3] 0 0
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Timepoint [4] 0 0
3 days
Secondary outcome [5] 0 0
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Timepoint [6] 0 0
3 days
Secondary outcome [7] 0 0
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Timepoint [8] 0 0
3 days
Secondary outcome [9] 0 0
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Timepoint [10] 0 0
3 days
Secondary outcome [11] 0 0
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Timepoint [11] 0 0
1 day
Secondary outcome [12] 0 0
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Timepoint [12] 0 0
3 days
Secondary outcome [13] 0 0
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Timepoint [13] 0 0
1 day
Secondary outcome [14] 0 0
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Timepoint [14] 0 0
3 days
Secondary outcome [15] 0 0
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Timepoint [15] 0 0
1 day
Secondary outcome [16] 0 0
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Timepoint [16] 0 0
3 days
Secondary outcome [17] 0 0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [17] 0 0
1 day
Secondary outcome [18] 0 0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [18] 0 0
5 days
Secondary outcome [19] 0 0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [19] 0 0
1 day
Secondary outcome [20] 0 0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [20] 0 0
5 days
Secondary outcome [21] 0 0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [21] 0 0
1 day
Secondary outcome [22] 0 0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [22] 0 0
5 days
Secondary outcome [23] 0 0
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [23] 0 0
1 day
Secondary outcome [24] 0 0
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [24] 0 0
5 days
Secondary outcome [25] 0 0
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [25] 0 0
1 day
Secondary outcome [26] 0 0
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [26] 0 0
5 days
Secondary outcome [27] 0 0
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [27] 0 0
1 day
Secondary outcome [28] 0 0
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [28] 0 0
5 days
Secondary outcome [29] 0 0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [29] 0 0
1 day
Secondary outcome [30] 0 0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [30] 0 0
5 days
Secondary outcome [31] 0 0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [31] 0 0
1 day
Secondary outcome [32] 0 0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [32] 0 0
5 days
Secondary outcome [33] 0 0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Timepoint [33] 0 0
6 days
Secondary outcome [34] 0 0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Timepoint [34] 0 0
6 days
Secondary outcome [35] 0 0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Timepoint [35] 0 0
6 days
Secondary outcome [36] 0 0
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
Timepoint [36] 0 0
6 days
Secondary outcome [37] 0 0
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
Timepoint [37] 0 0
6 days
Secondary outcome [38] 0 0
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
Timepoint [38] 0 0
6 days
Secondary outcome [39] 0 0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Timepoint [39] 0 0
6 days
Secondary outcome [40] 0 0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Timepoint [40] 0 0
6 days
Secondary outcome [41] 0 0
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [41] 0 0
19 days
Secondary outcome [42] 0 0
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [42] 0 0
19 days
Secondary outcome [43] 0 0
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [43] 0 0
19 days
Secondary outcome [44] 0 0
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [44] 0 0
19 days
Secondary outcome [45] 0 0
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [45] 0 0
19 days
Secondary outcome [46] 0 0
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [46] 0 0
19 days
Secondary outcome [47] 0 0
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [47] 0 0
19 days
Secondary outcome [48] 0 0
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [48] 0 0
19 days
Secondary outcome [49] 0 0
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Timepoint [49] 0 0
19 days
Secondary outcome [50] 0 0
Urine concentrations of ACHN-789 after single dose administration
Timepoint [50] 0 0
1 day
Secondary outcome [51] 0 0
Urine concentrations of ACHN-383 after single-dose administration
Timepoint [51] 0 0
3 days
Secondary outcome [52] 0 0
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Timepoint [52] 0 0
1 day
Secondary outcome [53] 0 0
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Timepoint [53] 0 0
5 days
Secondary outcome [54] 0 0
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Timepoint [54] 0 0
19 days

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2017
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Site - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Achaogen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel J Cloutier, PharmD
Address 0 0
Achaogen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03163550