PharmacokineticsPhase 1NCT02560363

A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects

A Phase 1 study testing AZD9977 immediate release (IR) oral suspension, AZD9977 extended release (ER) capsules [fast] and AZD9977 extended release (ER) capsules [intermediate] in people with Pharmacokinetics and Healthy Male Subjects, run by AstraZeneca at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is an open-label, randomized, cross over single oral dose study to compare the pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in Part B in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics, Healthy Male Subjects, Safety
What is being tested?: AZD9977 immediate release (IR) oral suspension, AZD9977 extended release (ER) capsules [fast] and AZD9977 extended release (ER) capsules [intermediate]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2015to Jan 2016
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture.
Male subjects have to comply with the restrictions for sexual activity provided to them.
Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg.
Subject judged likely to complete and agree to eat a specified high-fat, high-calorie standardized FDA breakfast.
Able to understand, read and speak the English language.

Who cannot join

History of any clinically significant 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 in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, as judged by the investigator.
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.
Abnormal findings in vital signs, after 10 minutes resting in the supine position, defined as any of the following:

Show all 31Show fewer

Systolic blood pressure (SBP) < 90 mmHg or ≥ 140 mmHg
Diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg
Pulse < 45 or > 90 bpm
Any clinically important abnormalities in rhythm, conduction or morphology of the electrocardiogram (ECG) at screening or pre-dose, as considered by the investigator.
Prolonged QTcF > 450 ms or family history of long QT syndrome.
PR (PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
PR (PQ) interval prolongation > 240 ms; intermittent second (history of Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block or AV dissociation.
Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB) or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of ventricular hypertrophy or pre-excitation.
Serum potassium higher than 5.0 mmol/L at screening or admission to the study center (Day -1).
Known or suspected history of drug abuse, as judged by the investigator.
Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Positive screen for drugs of abuse, alcohol or cotinine at screening or admission to the study center.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977.
Excessive intake of caffeine containing drinks or food (e.g., coffee, tea and chocolate) as judged by the investigator.
Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to first dose of AZD9977.
Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during 2 weeks prior to 1st dosing in Part A, or longer if the medication has a long half-life.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest.
Subjects who have previously received AZD9977
Involvement of any AstraZeneca, PAREXEL, or study site employee or their close relatives.
Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
Subjects who are vegans, vegetarians or have medical dietary restrictions.
Subjects who cannot communicate reliably with the investigator.
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
Harrow

Other trials in United Kingdom

About this study

Official title: An Open-label, Randomized, Cross Over Single Oral Dose Study Comparing the Pharmacokinetics of Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects

Read the detailed description

This is an open-label, randomized, cross over single oral dose study to compare the pharmacokinetics of three different extended-release formulations and an immediate-release formulation (reference) of AZD9977 in Part A and the influence of food in Part B in healthy male subjects

Conditions: Pharmacokinetics, Healthy Male Subjects, Safety, Food Effect
Being tested: AZD9977 immediate release (IR) oral suspension, AZD9977 extended release (ER) capsules [fast], AZD9977 extended release (ER) capsules [intermediate], AZD9977 extended release (ER) capsules [slow]
Keywords: AZD9977, Safety, Tolerability, Pharmacokinetics, Food effect, AZD9977 capsules, AZD9977 suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD9977 immediate release (IR) oral suspensionDrug
120 mg (4.8 mL x 25 mg/mL) oral suspension, single dose
AZD9977 extended release (ER) capsules [fast]Drug
120 mg (2 x 60mg capsules) single dose
AZD9977 extended release (ER) capsules [intermediate]Drug
120 mg (2 x 60mg capsules) single dose
AZD9977 extended release (ER) capsules [slow]Drug
120 mg (2 x 60mg capsules) single dose

Study groups in NCT02560363
Study group	Role	What they receive
Treatment sequence 1	Experimental	Period 1:Fast ER formulation of AZD9977 Period 2:Intermediate ER formulation of AZD9977 Period 3:Slow ER formulation of AZD9977 Period 4:IR formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food Receives: Drug: AZD9977 immediate release (IR) oral suspension; Drug: AZD9977 extended release (ER) capsules [fast]; Drug: AZD9977 extended release (ER) capsules [intermediate]; Drug: AZD9977 extended release (ER) capsules [slow]
Treatment sequence 2	Experimental	Period 1:Intermediate ER formulation of AZD9977 Period 2:IR formulation of AZD9977 Period 3:Fast ER formulation of AZD9977 Period 4:Slow ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food Receives: Drug: AZD9977 immediate release (IR) oral suspension; Drug: AZD9977 extended release (ER) capsules [fast]; Drug: AZD9977 extended release (ER) capsules [intermediate]; Drug: AZD9977 extended release (ER) capsules [slow]
Treatment sequence 3	Experimental	Period 1:Slow ER formulation of AZD9977 Period 2:Fast ER formulation of AZD9977 Period 3:IR formulation of AZD9977 Period 4:Intermediate ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food Receives: Drug: AZD9977 immediate release (IR) oral suspension; Drug: AZD9977 extended release (ER) capsules [fast]; Drug: AZD9977 extended release (ER) capsules [intermediate]; Drug: AZD9977 extended release (ER) capsules [slow]
Treatment sequence 4	Experimental	Period 1:IR formulation of AZD9977 Period 2:Slow ER formulation of AZD9977 Period 3:Intermediate ER formulation of AZD9977 Period 4:Fast ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food Receives: Drug: AZD9977 immediate release (IR) oral suspension; Drug: AZD9977 extended release (ER) capsules [fast]; Drug: AZD9977 extended release (ER) capsules [intermediate]; Drug: AZD9977 extended release (ER) capsules [slow]

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC)
Relative bioavailability (Frel [AUC]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-t)
Relative bioavailability (Frel [AUC0-t]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-24)
Relative bioavailability (Frel [AUC0-24]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (Cmax)
Relative bioavailability (Frel [Cmax]) by assessement of the ratio of AUC (Observed maximum plasma concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel (AUC)
Relative bioavailability (Frel [AUC]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) after dosing of an extended-release formulation under fed and fasting conditions
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(AUC0-t)
Relative bioavailability (Frel [AUC0-t]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) after dosing of an extended-release formulation under fed and fasting conditions
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(AUC0-24)
Relative bioavailability (Frel [AUC0-24]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) after dosing of an extended-release formulation under fed and fasting conditions
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(Cmax)
Relative bioavailability (Frel[Cmax]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) after dosing of an extended-release formulation under fed and fasting conditions
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day

Secondary outcomes (7)

Safety and tolerabilty of AZD9977 by assessment of the number of adverse events and the number of subjects with adverse events
To assess the safety and tolerability of single doses of AZD9977
Measured: From screening to post-study visit, up to 10 weeks
Safety and tolerabilty of AZD9977 by assessment of cardiac telemetry
To assess the safety and tolerability of single doses of AZD9977
Measured: On Day -1 and pre-dose until 24 hours post dose on Day 1
Safety and tolerabilty of AZD9977 by assessment of blood pressure
To assess the safety and tolerability of single doses of AZD9977
Measured: From screening to post-study visit, up to 10 weeks
Safety and tolerabilty of AZD9977 by assessment of pulse
To assess the safety and tolerability of single doses of AZD9977
Measured: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of electrocardiogram
To assess the safety and tolerability of single doses of AZD9977
Measured: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of physical examination
This is a composite of the general appearance, skin, cardiovascular, respiratory, abdomen, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Measured: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of safety laboratory tests
This is a composite of clinical chemistry, hematology and urinalysis
Measured: From screening to post-study visit, up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Jan 2016

First posted25 Sep 2015 (estimated)
Study startNov 2015
Primary completionJan 2016 (estimated)
Study completionJan 2016 (estimated)

Why it stopped: Has been terminated before FSFV.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies 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: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02560363
Sponsor's protocol ID: D6400C00003
Other IDs: 2015-002807-26, 2015
Status last verified: Jan 2016
First submitted: 24 Sep 2015
Last updated: 11 Jan 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Cross Over Single Oral Dose Study Comparing the Pharmacokinetics of Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02560363
Acronym / sponsor ID: D6400C00003
Conditions: Pharmacokinetics, Healthy Male Subjects, Safety, Food Effect
Keywords: AZD9977, Safety, Tolerability, Pharmacokinetics, Food effect, AZD9977 capsules, AZD9977 suspension
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Has been terminated before FSFV.
Enrolment: 0 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jan 2016 (estimated)
Study completion: Jan 2016 (estimated)
First posted: 25 Sep 2015 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: AZD9977 immediate release (IR) oral suspension, Drug: AZD9977 extended release (ER) capsules [fast], Drug: AZD9977 extended release (ER) capsules [intermediate], Drug: AZD9977 extended release (ER) capsules [slow]Period 1:Fast ER formulation of AZD9977 Period 2:Intermediate ER formulation of AZD9977 Period 3:Slow ER formulation of AZD9977 Period 4:IR formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food
Treatment sequence 2	Experimental	Drug: AZD9977 immediate release (IR) oral suspension, Drug: AZD9977 extended release (ER) capsules [fast], Drug: AZD9977 extended release (ER) capsules [intermediate], Drug: AZD9977 extended release (ER) capsules [slow]Period 1:Intermediate ER formulation of AZD9977 Period 2:IR formulation of AZD9977 Period 3:Fast ER formulation of AZD9977 Period 4:Slow ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food
Treatment sequence 3	Experimental	Drug: AZD9977 immediate release (IR) oral suspension, Drug: AZD9977 extended release (ER) capsules [fast], Drug: AZD9977 extended release (ER) capsules [intermediate], Drug: AZD9977 extended release (ER) capsules [slow]Period 1:Slow ER formulation of AZD9977 Period 2:Fast ER formulation of AZD9977 Period 3:IR formulation of AZD9977 Period 4:Intermediate ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food
Treatment sequence 4	Experimental	Drug: AZD9977 immediate release (IR) oral suspension, Drug: AZD9977 extended release (ER) capsules [fast], Drug: AZD9977 extended release (ER) capsules [intermediate], Drug: AZD9977 extended release (ER) capsules [slow]Period 1:IR formulation of AZD9977 Period 2:Slow ER formulation of AZD9977 Period 3:Intermediate ER formulation of AZD9977 Period 4:Fast ER formulation of AZD9977 Period 5:Fast, intermediate or slow ER formulation with food

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture.
Male subjects have to comply with the restrictions for sexual activity provided to them.
Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg.
Subject judged likely to complete and agree to eat a specified high-fat, high-calorie standardized FDA breakfast.

Key exclusion criteria (31 listed)

History of any clinically significant 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 in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, as judged by the investigator.
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.

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
AZD9977 immediate release (IR) oral suspension120 mg (4.8 mL x 25 mg/mL) oral suspension, single dose	Drug	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4
AZD9977 extended release (ER) capsules [fast]120 mg (2 x 60mg capsules) single dose	Drug	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4
AZD9977 extended release (ER) capsules [intermediate]120 mg (2 x 60mg capsules) single dose	Drug	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4
AZD9977 extended release (ER) capsules [slow]120 mg (2 x 60mg capsules) single dose	Drug	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4

Primary outcome

Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-t)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC0-t]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-24)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC0-24]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (Cmax)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [Cmax]) by assessement of the ratio of AUC (Observed maximum plasma concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel (AUC)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) after dosing of an extended-release formulation under fed and fasting conditions
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(AUC0-t)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC0-t]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) after dosing of an extended-release formulation under fed and fasting conditions
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(AUC0-24)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel [AUC0-24]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) after dosing of an extended-release formulation under fed and fasting conditions
Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(Cmax)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
Relative bioavailability (Frel[Cmax]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) after dosing of an extended-release formulation under fed and fasting conditions

7 secondary outcomes

Safety and tolerabilty of AZD9977 by assessment of the number of adverse events and the number of subjects with adverse events
Time frame: From screening to post-study visit, up to 10 weeks
Safety and tolerabilty of AZD9977 by assessment of cardiac telemetry
Time frame: On Day -1 and pre-dose until 24 hours post dose on Day 1
Safety and tolerabilty of AZD9977 by assessment of blood pressure
Time frame: From screening to post-study visit, up to 10 weeks
Safety and tolerabilty of AZD9977 by assessment of pulse
Time frame: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of electrocardiogram
Time frame: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of physical examination
Time frame: From screening to post-study visit, up to 10 weeks
Safety and tolerability of AZD9977 by assessment of safety laboratory tests
Time frame: From screening to post-study visit, up to 10 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.

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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.

Muna Albayaty, MBChB, MSc, MFPM principal investigator

Parexel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 31 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: withdrawn, as of the sponsor's last update on 11 Jan 2016. 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC) (time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560363.

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 11 Jan 2016.