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

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ClinicalTrials.gov Identifier: NCT01889160
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax Drug: AZD4721 Solution Drug: AZD4721 Placebo Drug: AZD4721 Suspension Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 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 Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889160


Locations
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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: James Ritter, MD Quintiles London UK
Study Director: Bengt Larsson, MD Astrazeneca Molndal, Sweden
Study Chair: Stuart Oliver, MD Astrazeneca UK

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01889160     History of Changes
Other Study ID Numbers: D5200C00001
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by AstraZeneca:
Healthy volunteers, Phase 1

Additional relevant MeSH terms:
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Pharmaceutical Solutions