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

November 29, 2017 updated by: Achaogen, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Healthy volunteers
Drug: Placebo
Oral dose
Drug: ACHN-383
Oral dose
Drug: ACHN-789
Oral dose
Experimental: Cohort 2
Healthy volunteers
Drug: Placebo
Oral dose
Drug: ACHN-383
Oral dose
Drug: ACHN-789
Oral dose
Experimental: Cohort 3
Healthy volunteers
Drug: Placebo
Oral dose
Drug: ACHN-383
Oral dose
Drug: ACHN-789
Oral dose
Experimental: Cohort 4
Healthy volunteers
Drug: Placebo
Oral dose
Drug: ACHN-383
Oral dose
Drug: ACHN-789
Oral dose
Experimental: Cohort 5
Healthy volunteers
Drug: Placebo
Oral dose
Drug: ACHN-383
Oral dose
Drug: ACHN-789
Oral dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Time Frame: 26 days
26 days
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Time Frame: 26 days
26 days
Incidence and severity of adverse events
Time Frame: 26 days
26 days
Changes from baseline in the QTcF interval
Time Frame: 19 days
19 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Time Frame: 1 day
1 day
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Time Frame: 3 days
3 days
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
5 days
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 1 day
1 day
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 5 days
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
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
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
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
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
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
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
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
6 days
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Time Frame: 19 days
19 days
Urine concentrations of ACHN-789 after single dose administration
Time Frame: 1 day
1 day
Urine concentrations of ACHN-383 after single-dose administration
Time Frame: 3 days
3 days
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Time Frame: 1 day
1 day
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Time Frame: 5 days
5 days
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Time Frame: 19 days
19 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Achaogen, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniel J Cloutier, PharmD, Achaogen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACHN-172-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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