Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels

June 24, 2015 updated by: AstraZeneca

A Phase I Single-blind, Randomised, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AZD4721 Solution After Single Ascending Doses, and to Compare the Oral Bioavailability of Single Doses of Solution and Suspension in Healthy Subjects

Study to investigate the safety profile of AZD4721 after single doses at different dose levels

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.

Detailed Description

A study to investigate safety and tolerability of single ascending doses of AZD4721 given to healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a suspension.

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.
44

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG )
  2. Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential
  3. Volunteers should have a BMI between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).

Exclusion Criteria:

  1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
  2. Current smokers or those who have smoked or used nicotine products within the previous 3 months

2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator

4. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Part A Active
AZD4721 Solution
Drug: AZD4721 Solution
1-9 mg/mL liquid solution
Placebo Comparator: Part A Placebo
Placebo for AZD4721
Drug: AZD4721 Placebo
Liquid solution
Experimental: Part B solution
AZD4721 Solution
Drug: AZD4721 Solution
1-9 mg/mL liquid solution
Active Comparator: Part B Suspension
AZD4721 Suspension
Drug: AZD4721 Suspension
9 mg/g liquid suspension

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
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments, including serial blood neutrophil count
Time Frame: From Screening to follow up ( maximum 7 weeks)
From Screening to follow up ( maximum 7 weeks)

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
Description of the pharmacokinetic(PK) profile for in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z).
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of: area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)), from time zero to the time of last quantifiable concentration (AUC(0 last))
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of from time zero extrapolated to infinity (AUC), apparent clearance for parent drug estimated as dose divided by AUC (CL/F; AZD4721 only)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile in terms of apparent volume of distribution during terminal phase (Vz/F; AZD4721 only), mean residence time (MRT, AZD4721 only), lag-time (T-lag, AZD4721 only), dose-normalized AUC (AUC/D) and Cmax (Cmax/D)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of effective half-life (t½(eff)), time of last quantifiable concentration (tlast), predicted accumulation ratio (Rac,pred)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of the time interval and number of data points included in the log-linear regression to determine terminal half-life (z,Interval and z,N)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of the regression coefficient for calculation of the terminal rate constant (Rsq), and the percentage of area under the curve to infinity obtained by extrapolation (%AUCex).
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of the metabolic ratios (ratio of metabolite to parent) for AUC and Cmax (MRAUC and MRCmax)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose

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.
AstraZeneca

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.
  • Principal Investigator: James Ritter, MD, Quintiles London UK
  • Study Director: Bengt Larsson, MD, AstraZeneca Mölndal, Sweden
  • Study Chair: Stuart Oliver, MD, AstraZeneca UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

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.
July 1, 2013

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.
December 1, 2013

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.
December 1, 2013

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).
June 24, 2013

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.
June 27, 2013

First Posted (Estimate)

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.
June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
June 25, 2015

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.
June 24, 2015

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.
June 1, 2015

More Information

Terms related to this study

Keywords

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.
  • D5200C00001

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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