SafetyPhase 1NCT02484729

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males

A Phase 1 study testing AZD9977, oral suspension and AZD9977, oral solution in people with Safety and Tolerability, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Safety, Tolerability, Pharmacokinetics
What is being tested?: AZD9977, oral suspension and AZD9977, oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2015to Nov 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Optional: Provision of signed and dated written informed consent for genetic research.
If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.
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 potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study.
History or presence of 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 dosing in Part A or the first dose of AZD9977 in Part B.
Any clinically significant abnormalities in hematology, clinical chemistry or urinalysis results, as judged by the investigator.
Any positive result at screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibodies.
Abnormal findings in vital signs, after 10 minutes resting in the supine position, defined as any of the following:

Show all 41Show 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 > 240ms; intermittent second or third degree atrioventricular (AV) block, or AV dissociation.
Wenckebach block while asleep is not exclusive.
Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms.
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 previous 3 months.
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 dosing in Part A or the first dose of AZD9977 in Part B.
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 dosing in Part A or the first dose of AZD9977 in Part B, or longer if the medication has a long half-life.
Plasma donation within one month of screening or any blood donation/blood loss > 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 dosing in Part A or the first dose of AZD9977 in Part B in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest.
Note: Subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
Involvement of any AstraZeneca 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 or have medical dietary restrictions (vegetarians may be included in the study).
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.
In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
Previous bone marrow transplant.
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Criteria applicable to Part B only:
Subjects with pacemakers or other implanted electro-medical devices.
Subjects with swallowing disorders.
Subjects with pre-planned MRI examination.
Subjects not willing to have an abdominal X-ray performed if the IntelliCap® capsule has not been retrieved within one week after ingestion.

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: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Access the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Single Ascending Dose Administration to Healthy Male Subjects

This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design. The study will be performed at a single study centre.

Read the detailed description

This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design with oral solution as reference. The study will be performed at a single study centre.

Conditions: Safety, Tolerability, Pharmacokinetics, Healthy Subjects
Being tested: AZD9977, oral suspension, Placebo, oral suspension, AZD9977, oral solution
Keywords: AZD9977, Safety, Tolerability, Pharmacokinetics, First-in-human, Single Ascending Dose, Regional absorption, Healthy male subjects

What participants receive

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

AZD9977, oral suspensionDrug
Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)
Placebo, oral suspensionDrug
Matching placebo
AZD9977, oral solutionDrug
AZD9977, single dose of oral solution in Part B as reference

Study groups in NCT02484729
Study group	Role	What they receive
AZD9977 oral suspension, single doses	Experimental	In Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule Receives: Drug: AZD9977, oral suspension
Placebo, oral suspension, single doses	Placebo comparator	In Part A up to 10 cohorts with single doses with matching placebo to AZD9977 Receives: Drug: Placebo, oral suspension
AZD9977, oral solution, single dose	Experimental	In Part B, of oral solution of AZD9977 will be used as reference Receives: Drug: AZD9977, oral solution

What is being measured

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

Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing
Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis
To assess the safety and tolerability of single ascending doses of AZD9977
Measured: For up to 45 days, i.e. from Screening to Follow-up

Secondary outcomes (10)

Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Observed Maximum Concentration (Cmax)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Time to Maximum Observed Plasma Concentration (t Max)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Apparent Clearance (CL/F)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Apparent Volume of Distribution (Vz/F)
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Measured: Pre-dose and post-dose upto 48 hrs
Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]
To assess urine pharmacokinetic parameters following single ascending doses of AZD9977
Measured: Pre-dose and post-dose upto 48 hrs
Fraction Excreted Unchanged in Urine[Fe (0-48)]
To assess percentage of the total drug excreted in the urine that was unchanged following single ascending doses of AZD9977
Measured: Pre-dose and post-dose upto 48 hrs
Renal Clearance of Drug From Plasma [CLR (0-48)]
To assess urine pharmacokinetic parameters following single ascending doses of AZD9977
Measured: Pre-dose and post-dose upto 48 hrs

Timeline

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

Jul 2015Nov 2015

First posted30 Jun 2015 (estimated)
Study startJul 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SafetyStudies 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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02484729
Sponsor's protocol ID: D6400C00001
Other IDs: 2015-000877-11, 2015
Status last verified: Mar 2017
First submitted: 18 Jun 2015
Last updated: 28 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Access the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Single Ascending Dose Administration to Healthy Male Subjects
ClinicalTrials.gov ID: NCT02484729
Acronym / sponsor ID: D6400C00001
Conditions: Safety, Tolerability, Pharmacokinetics, Healthy Subjects
Keywords: AZD9977, Safety, Tolerability, Pharmacokinetics, First-in-human, Single Ascending Dose, Regional absorption, Healthy male subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 30 Jun 2015 (estimated)
Results: Posted 24 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design with oral solution as reference. The study will be performed at a single study centre.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
AZD9977 oral suspension, single doses	Experimental	Drug: AZD9977, oral suspensionIn Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule
Placebo, oral suspension, single doses	Placebo comparator	Drug: Placebo, oral suspensionIn Part A up to 10 cohorts with single doses with matching placebo to AZD9977
AZD9977, oral solution, single dose	Experimental	Drug: AZD9977, oral solutionIn Part B, of oral solution of AZD9977 will be used as reference

Who may qualify

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

Key inclusion criteria (7 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 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Optional: Provision of signed and dated written informed consent for genetic research.

Key exclusion criteria (41 listed)

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study.
History or presence of 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 dosing in Part A or the first dose of AZD9977 in Part B.
Any clinically significant abnormalities in hematology, clinical chemistry or urinalysis results, as judged by the investigator.
Any positive result at screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibodies.

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, oral suspensionSingle ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)	Drug	AZD9977 oral suspension, single doses
Placebo, oral suspensionMatching placebo	Drug	Placebo, oral suspension, single doses
AZD9977, oral solutionAZD9977, single dose of oral solution in Part B as reference	Drug	AZD9977, oral solution, single dose

Primary outcome

Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry
Time frame: For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis
Time frame: For up to 45 days, i.e. from Screening to Follow-up
To assess the safety and tolerability of single ascending doses of AZD9977

10 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.
Time frame: Pre-dose and post-dose upto 48 hrs
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)
Time frame: Pre-dose and post-dose upto 48 hrs
Observed Maximum Concentration (Cmax)
Time frame: Pre-dose and post-dose upto 48 hrs
Time to Maximum Observed Plasma Concentration (t Max)
Time frame: Pre-dose and post-dose upto 48 hrs
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
Time frame: Pre-dose and post-dose upto 48 hrs
Apparent Clearance (CL/F)
Time frame: Pre-dose and post-dose upto 48 hrs
Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose and post-dose upto 48 hrs
Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]
Time frame: Pre-dose and post-dose upto 48 hrs
Fraction Excreted Unchanged in Urine[Fe (0-48)]
Time frame: Pre-dose and post-dose upto 48 hrs
Renal Clearance of Drug From Plasma [CLR (0-48)]
Time frame: Pre-dose and post-dose upto 48 hrs

Results and safety

Results posted to the registry on 24 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A- Placebo	16	16
Part A - 5 mg AZD9977	6	6
Part A - 25 mg AZD9977	6	6
Part A - 100 mg AZD9977	6	6
Part A - 200 mg AZD9977	5	5
Part A - 400 mg AZD9977	6	6
Part A - 800 mg AZD9977	5	5
Part A - 800 mg AZD9977 (Split Doses)	6	6
Part A - 1200 mg AZD9977 (Split Doses)	6	6
Part B	8	7

Primary outcome: Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events

Time frame: For up to 45 days, i.e. from Screening to Follow-up. Number. Unit: percentage of participants

Measure	Part A- Placebo n = 16	Part A - 5 mg AZD9977 n = 6	Part A - 25 mg AZD9977 n = 6	Part A - 100 mg AZD9977 n = 6	Part A - 200 mg AZD9977 n = 5	Part A - 400 mg AZD9977 n = 6	Part A - 800 mg AZD9977 n = 5	Part A - 800 mg AZD9977 (Split Doses) n = 6	Part A - 1200 mg AZD9977 (Split Doses) n = 6	Part B n = 8
Value	43.8	16.7	33.3	33.3	20.0	33.3	0	33.3	16.7	37.5

Population analysed: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

Primary outcome: Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate

Time frame: For up to 45 days, i.e. from Screening to Follow-up. Number. Unit: Number of Participants

Measure	Part A- Placebo n = 16	Part A - 5 mg AZD9977 n = 6	Part A - 25 mg AZD9977 n = 6	Part A - 100 mg AZD9977 n = 6	Part A - 200 mg AZD9977 n = 5	Part A - 400 mg AZD9977 n = 6	Part A - 800 mg AZD9977 n = 5	Part A - 800 mg AZD9977 (Split Doses) n = 6	Part A - 1200 mg AZD9977 (Split Doses) n = 6	Part B n = 8
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

Primary outcome: Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms

Time frame: For up to 45 days, i.e. from Screening to Follow-up. Number. Unit: Number of participants

Measure	Part A- Placebo n = 16	Part A - 5 mg AZD9977 n = 6	Part A - 25 mg AZD9977 n = 6	Part A - 100 mg AZD9977 n = 6	Part A - 200 mg AZD9977 n = 5	Part A - 400 mg AZD9977 n = 6	Part A - 800 mg AZD9977 n = 5	Part A - 800 mg AZD9977 (Split Doses) n = 6	Part A - 1200 mg AZD9977 (Split Doses) n = 6	Part B n = 8
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

Primary outcome: Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry

Time frame: For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing. Number. Unit: Number of Participants

Measure	Part A- Placebo n = 16	Part A - 5 mg AZD9977 n = 6	Part A - 25 mg AZD9977 n = 6	Part A - 100 mg AZD9977 n = 6	Part A - 200 mg AZD9977 n = 5	Part A - 400 mg AZD9977 n = 6	Part A - 800 mg AZD9977 n = 5	Part A - 800 mg AZD9977 (Split Doses) n = 6	Part A - 1200 mg AZD9977 (Split Doses) n = 6	Part B n = 8
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A- Placebo	0 of 16 (0%)	7 of 16 (43.8%)	Not reported
Part A - 5 mg AZD9977	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Part A - 25 mg AZD9977	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Part A - 100 mg AZD9977	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Part A - 200 mg AZD9977	0 of 5 (0%)	1 of 5 (20%)	Not reported
Part A - 400 mg AZD9977	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Part A - 800 mg AZD9977	0 of 5 (0%)	0 of 5 (0%)	Not reported
Part A - 800 mg AZD9977 (Split Doses)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Part A - 1200 mg AZD9977 (Split Doses)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Part B	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge

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, Dr. principal investigator

PAREXEL Early Phase Clinical Unit London, Level 7, Northwick Park Hospital, Watford Road, Harrow, Middlesex HA1 3UJ, United Kingdom

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 AZD9977, oral suspension and AZD9977, oral solution in people with Safety and Tolerability, 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 7 inclusion and 41 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 28 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events (time frame: For up to 45 days, i.e. from Screening to Follow-up). The study lists 9 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 NCT02484729.

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 28 Apr 2017.