Healthy VolunteersPhase 1NCT03163550
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
A Phase 1 study testing ACHN-383 and ACHN-789 in people with Healthy Volunteers, run by Achaogen, Inc. at 1 site in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACHN-383 and ACHN-789
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 17 May 2017to 15 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Healthy Volunteers
- Being tested
- ACHN-383, ACHN-789, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHN-383Drug
Oral dose
ACHN-789Drug
Oral dose
PlaceboDrug
Oral dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Healthy volunteers Receives: Drug: ACHN-383; Drug: ACHN-789; Drug: Placebo |
| Cohort 2 | Experimental | Healthy volunteers Receives: Drug: ACHN-383; Drug: ACHN-789; Drug: Placebo |
| Cohort 3 | Experimental | Healthy volunteers Receives: Drug: ACHN-383; Drug: ACHN-789; Drug: Placebo |
| Cohort 4 | Experimental | Healthy volunteers Receives: Drug: ACHN-383; Drug: ACHN-789; Drug: Placebo |
| Cohort 5 | Experimental | Healthy volunteers Receives: Drug: ACHN-383; Drug: ACHN-789; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Measured: 26 days
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Measured: 26 days
Incidence and severity of adverse events
Measured: 26 days
Changes from baseline in the QTcF interval
Measured: 19 days
Secondary outcomes (54)
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Measured: 1 day
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Measured: 3 days
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 5 days
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 1 day
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 days
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Measured: 19 days
Urine concentrations of ACHN-789 after single dose administration
Measured: 1 day
Urine concentrations of ACHN-383 after single-dose administration
Measured: 3 days
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Measured: 1 day
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Measured: 5 days
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start17 May 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Cloutier, PharmD, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163550
- Sponsor's protocol ID
- ACHN-172-001
- Status last verified
- Nov 2017
- First submitted
- 15 May 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03163550
- Acronym / sponsor ID
- ACHN-172-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ACHN-383, Drug: ACHN-789, Drug: PlaceboHealthy volunteers |
| Cohort 2 | Experimental | Drug: ACHN-383, Drug: ACHN-789, Drug: PlaceboHealthy volunteers |
| Cohort 3 | Experimental | Drug: ACHN-383, Drug: ACHN-789, Drug: PlaceboHealthy volunteers |
| Cohort 4 | Experimental | Drug: ACHN-383, Drug: ACHN-789, Drug: PlaceboHealthy volunteers |
| Cohort 5 | Experimental | Drug: ACHN-383, Drug: ACHN-789, Drug: PlaceboHealthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACHN-383Oral dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| ACHN-789Oral dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboOral dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
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
54 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Cloutier, PharmD study director
Achaogen, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACHN-383 and ACHN-789 in people with Healthy Volunteers, run by Achaogen, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin) (time frame: 26 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.