Chronic Obstructive Pulmonary Disease (COPD).Phase 1NCT01962935
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069
A Phase 1 study testing AZD4721 and AZD5069 in people with Chronic Obstructive Pulmonary Disease (COPD)., run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD).
- What is being tested?
- AZD4721 and AZD5069
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Jun 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Provision of signed and dated, written informed consent prior to any study specific procedures.
- 2.Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG and performed before first dose administration.).
- 3.Healthy volunteers should have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).
Who cannot join
- Pyrexial with a body temperature higher than 37.7°C at Day -1 (Visit 2), or as judged by the investigator.
- Screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (Visit 1).
- 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 the previous 90 days, or history of skin abscesses within the previous 90 days.
- Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (Visit 1), as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4721 After Once Daily Administration of Multiple Ascending Doses for 10 Days, and an Open-label Comparison With the Pharmacodynamics of AZD5069 Given Twice Daily for 3 Days
Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069
Read the detailed description
The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of AZD5069 given twice daily for 3 days
- Being tested
- AZD4721, Placebo, AZD5069
- Keywords
- Healthy volunteer, Multiple ascending dose
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4721Drug
Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily
PlaceboDrug
Part A - multiple ascending dose daily
AZD5069Drug
Part B - one dose decided after part A, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Part A AZD4721 | Experimental | Part A of the study, multiple ascending doses of AZD4721 will be administrated once daily for 10 days Receives: Drug: AZD4721 |
| Placebo | Placebo comparator | Part A of the study, multiple ascending doses of matching Placebo will be administrated once a daily for 14 days Receives: Drug: Placebo |
| AZD5069, then AZD4721 | Active comparator | Part B of the study, subject will participate in two treatment periods (one with AZD5069 administrated for 3 days and the second period with AZD4721 administrated for 14 days) separated by a wash-out period of 6-10 days between the two periods. Receives: Drug: AZD4721; Drug: AZD5069 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments
Same for both part A and B
Measured: From Admission day -1 up to Follow up ( Max 12 weeks)
Description of neutrophils in terms of absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Part A AZD4721
Measured: Samples taken for part A day -1, Day 1 at predose,1h,2h,6h and 12h postdose, predose day 2,3,4,5,6,7,8,9,10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,36h,48h post last dose ( given day 10).
Description of neutrophils in terms of minimum ANC during first 24 hours on Day 1 [Part A only, ANCmin,Day 1], time of ANCmin,Day 1 [ANCtmin,Day 1], minimum ANC ratio during first 24 hours on Day 1 [Part A only, ANCmin ratio,Day 1]
Part A AZD4721
Measured: Samples taken for Part A Day 1 at predose, 1h,2h,6h12h and 24h postdose.
Descriptions of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss],
Part A AZD4721
Measured: Samples taken for Part A day10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Part A AZD4721
Measured: Samples taken for Part A day 10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Part B AZD5069
Measured: Part B visit 1 day -1, day 1 predose, 12h, day 2 predose, day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of neutrophils in terms of • time of ANCmin,Day 1 [ANCtmin,Day 1],
Part B AZD5069
Measured: Part B day 1 predose, 12h and 24h postdose
Description of neutrophile in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Part B AZD5069
Measured: Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Part B AZD5069
Measured: Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss]
Part B AZD4721
Measured: Samples taken for part B day -1, predose day 1,2,4,6,8,10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Description of neutrophils in terms of time of ANCmin,Day 1 [ANCtmin,Day 1],
Part B AZD4721
Measured: Samples taken for part B predose day 1
Description of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Part B AZD4721
Measured: Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Part B AZD4721
Measured: Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Secondary outcomes (18)
Description of the pharmacokinetic(PK) profile of AZD 4721 in terms of Maximum plasma concentration (Cmax), maximum plasma concentration divided by dose (Cmax/D), time to Cmax (tmax)
Following single dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval (AUCtau),), lag-time (tlag), ratio of metabolite AUCtau to parent AUCtau (MRAUC)
Following single dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of ratio of metabolite Cmax to parent Cmax (MRCmax)
Following single dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of Maximum plasma concentration (Css,max), maximum plasma concentration divided by dose (Css,max/D) time to Css,max (tss,max)
Following multiple dose administration of AZD4721Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of minimum plasma concentration (Css,min)), time to Css,min (tss,min) average concentration over the investigational product interval (Css,av)
Following multiple dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of peak to trough concentration ratio (Css,max/Css,min)), terminal rate constant (z), terminal half-life (t1/2λz)
Following multiple dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval at steady state (AUCss,tau), AUCss,tau divided by dose (AUCss,tau/D)
Following multiple dose administration of AZD4721Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of apparent clearance (CL/F), ), volume of distribution (Vz/F)
Following multiple dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 and metabolite in terms of ratio of metabolite AUCss,tau to parent AUCss,tau (MRAUCss,tau), ratio of metabolite Css,max to parent Css,max (MRCss,max)
Following multiple dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 and metabolite in terms of accumulation ratio for AUCtau (RAUCtau), and accumulation ratio for Cmax (RCmax).
Following multiple dose administration of AZD4721 Part A
Measured: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of Cumulative amount of AZD4721 and AZ13622093 excreted over the investigational product administration interval (Ae (0-tau))
Following multiple dose administration of AZD4721 Part A
Measured: Urine collection 24h from 0h-24 day 10
Description of the PK profile of AZD 4721 in terms of fraction of dose excreted into the urine over the dosing interval for AZD4721 (fe (0 tau)), and renal clearance (CLR).
Following multiple dose administration of AZD4721 Part A
Measured: Urine collection 24h from 0h-24 day 10
Description of PK Profile of AZD5069 in terms of observed global maximum concentration (Css,max), time to global Css,max (tss,max), observed global minimum concentration (Css,min)
Following multiple dosing of AZD5069 Part B
Measured: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of time to global Css,min (tss,min), average concentration over 24 hours (Css,av), peak to trough concentration ratio (Css,max/Css,min)
Following multiple dosing of AZD5069 Part B
Measured: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of AUC during the 12 hour interval after the morning dose(AUCtau,morning), AUC during the 12 hour dosing interval after the evening dose (AUCtau,evening)
Following multiple dosing of AZD5069 Part B
Measured: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of and area under the plasma concentration time curve 0 to 24 hours post morning dose (AUC(0 24h)).
Following multiple dosing of AZD5069 Part B
Measured: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD4721 in terms of maximum plasma concentration (Css,max), time to Css,max (tss,max), minimum plasma concentration (Css,min), time to Css,min (tss,min), average concentration over the dosing interval (Css,av)
Following multiple dosing of AZD4721 Part B
Measured: Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD4721 in terms of peak to trough concentration ratio (Css,max/Css,min), area under the plasma concentration time curve during the dosing interval (AUCss,tau), and apparent clearance (CL/F).
Following multiple dosing of AZD4721 Part B
Measured: Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD).Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard Siew, MD, Principal investigator, Quintiles London, UKBengt Larsson, MD, Study director, Astrazeneca Mölndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962935
- Sponsor's protocol ID
- D5200C00002
- Status last verified
- Jun 2015
- First submitted
- 11 Oct 2013
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4721 After Once Daily Administration of Multiple Ascending Doses for 10 Days, and an Open-label Comparison With the Pharmacodynamics of AZD5069 Given Twice Daily for 3 Days
- ClinicalTrials.gov ID
- NCT01962935
- Acronym / sponsor ID
- D5200C00002
- Keywords
- Healthy volunteer, Multiple ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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.
Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069
Detailed description
The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of AZD5069 given twice daily for 3 days
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A AZD4721 | Experimental | Drug: AZD4721Part A of the study, multiple ascending doses of AZD4721 will be administrated once daily for 10 days |
| Placebo | Placebo comparator | Drug: PlaceboPart A of the study, multiple ascending doses of matching Placebo will be administrated once a daily for 14 days |
| AZD5069, then AZD4721 | Active comparator | Drug: AZD4721, Drug: AZD5069Part B of the study, subject will participate in two treatment periods (one with AZD5069 administrated for 3 days and the second period with AZD4721 administrated for 14 days) separated by a wash-out period of 6-10 days between the two periods. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1.Provision of signed and dated, written informed consent prior to any study specific procedures.
- 2.Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG and performed before first dose administration.).
- 3.Healthy volunteers should have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).
Key exclusion criteria (4 listed)
- Pyrexial with a body temperature higher than 37.7°C at Day -1 (Visit 2), or as judged by the investigator.
- Screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (Visit 1).
- 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 the previous 90 days, or history of skin abscesses within the previous 90 days.
- Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (Visit 1), as determined by the investigator.
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 |
|---|---|---|
| AZD4721Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily | Drug | AZD5069, then AZD4721, Part A AZD4721 |
| PlaceboPart A - multiple ascending dose daily | Drug | Placebo |
| AZD5069Part B - one dose decided after part A, twice a day | Drug | AZD5069, then AZD4721 |
Primary outcome
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments
Time frame: From Admission day -1 up to Follow up ( Max 12 weeks)
Same for both part A and B
Description of neutrophils in terms of absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Time frame: Samples taken for part A day -1, Day 1 at predose,1h,2h,6h and 12h postdose, predose day 2,3,4,5,6,7,8,9,10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,36h,48h post last dose ( given day 10).
Part A AZD4721
Description of neutrophils in terms of minimum ANC during first 24 hours on Day 1 [Part A only, ANCmin,Day 1], time of ANCmin,Day 1 [ANCtmin,Day 1], minimum ANC ratio during first 24 hours on Day 1 [Part A only, ANCmin ratio,Day 1]
Time frame: Samples taken for Part A Day 1 at predose, 1h,2h,6h12h and 24h postdose.
Part A AZD4721
Descriptions of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss],
Time frame: Samples taken for Part A day10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Part A AZD4721
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Time frame: Samples taken for Part A day 10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Part A AZD4721
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Time frame: Part B visit 1 day -1, day 1 predose, 12h, day 2 predose, day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Part B AZD5069
Description of neutrophils in terms of • time of ANCmin,Day 1 [ANCtmin,Day 1],
Time frame: Part B day 1 predose, 12h and 24h postdose
Part B AZD5069
Description of neutrophile in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Time frame: Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Part B AZD5069
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Time frame: Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Part B AZD5069
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss]
Time frame: Samples taken for part B day -1, predose day 1,2,4,6,8,10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Part B AZD4721
Description of neutrophils in terms of time of ANCmin,Day 1 [ANCtmin,Day 1],
Time frame: Samples taken for part B predose day 1
Part B AZD4721
Description of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Time frame: Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Part B AZD4721
Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Time frame: Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Part B AZD4721
18 secondary outcomes
Description of the pharmacokinetic(PK) profile of AZD 4721 in terms of Maximum plasma concentration (Cmax), maximum plasma concentration divided by dose (Cmax/D), time to Cmax (tmax)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval (AUCtau),), lag-time (tlag), ratio of metabolite AUCtau to parent AUCtau (MRAUC)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of ratio of metabolite Cmax to parent Cmax (MRCmax)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of Maximum plasma concentration (Css,max), maximum plasma concentration divided by dose (Css,max/D) time to Css,max (tss,max)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of minimum plasma concentration (Css,min)), time to Css,min (tss,min) average concentration over the investigational product interval (Css,av)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of peak to trough concentration ratio (Css,max/Css,min)), terminal rate constant (z), terminal half-life (t1/2λz)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval at steady state (AUCss,tau), AUCss,tau divided by dose (AUCss,tau/D)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of apparent clearance (CL/F), ), volume of distribution (Vz/F)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 and metabolite in terms of ratio of metabolite AUCss,tau to parent AUCss,tau (MRAUCss,tau), ratio of metabolite Css,max to parent Css,max (MRCss,max)
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 and metabolite in terms of accumulation ratio for AUCtau (RAUCtau), and accumulation ratio for Cmax (RCmax).
Time frame: Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Description of the PK profile of AZD 4721 in terms of Cumulative amount of AZD4721 and AZ13622093 excreted over the investigational product administration interval (Ae (0-tau))
Time frame: Urine collection 24h from 0h-24 day 10
Description of the PK profile of AZD 4721 in terms of fraction of dose excreted into the urine over the dosing interval for AZD4721 (fe (0 tau)), and renal clearance (CLR).
Time frame: Urine collection 24h from 0h-24 day 10
Description of PK Profile of AZD5069 in terms of observed global maximum concentration (Css,max), time to global Css,max (tss,max), observed global minimum concentration (Css,min)
Time frame: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of time to global Css,min (tss,min), average concentration over 24 hours (Css,av), peak to trough concentration ratio (Css,max/Css,min)
Time frame: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of AUC during the 12 hour interval after the morning dose(AUCtau,morning), AUC during the 12 hour dosing interval after the evening dose (AUCtau,evening)
Time frame: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD5069 in terms of and area under the plasma concentration time curve 0 to 24 hours post morning dose (AUC(0 24h)).
Time frame: Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD4721 in terms of maximum plasma concentration (Css,max), time to Css,max (tss,max), minimum plasma concentration (Css,min), time to Css,min (tss,min), average concentration over the dosing interval (Css,av)
Time frame: Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Description of PK Profile of AZD4721 in terms of peak to trough concentration ratio (Css,max/Css,min), area under the plasma concentration time curve during the dosing interval (AUCss,tau), and apparent clearance (CL/F).
Time frame: Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
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 25 Jun 2015.
- CSR SynopsisLink provided by the sponsor.
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.
Leonard Siew, MD principal investigator
Quintiles London, UK
Bengt Larsson, MD study director
Astrazeneca Mölndal, Sweden
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 AZD4721 and AZD5069 in people with Chronic Obstructive Pulmonary Disease (COPD)., run by AstraZeneca at 1 site in United Kingdom.
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 3 inclusion and 4 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 25 Jun 2015. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments (time frame: From Admission day -1 up to Follow up ( Max 12 weeks)). The study lists 13 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 25 Jun 2015.