A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers

A Phase 1 study testing AZD4041 in people with Smoking Cessation, run by AstraZeneca at 2 sites in United States.

Completed

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

Trial summary

This is a Phase I, first-in-human (FIH), single-center, randomized, double-blind, placebo controlled, single ascending dose, sequential group study in healthy vasectomized male and female subjects of non-childbearing potential, aged 18 to 65 years. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: AZD4041
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 2 sitesUnited States
Study dates: 3 Oct 2019to 2 Jan 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this clinical study protocol.
Provision of signed and dated, written Informed Consent Form prior to any mandatory study specific procedures, sampling, and analyses.
Subjects must be ≥18 and less than or equal to 65 years of age at the time of signing the Informed Consent Form.
Individuals who are healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
Individuals who weigh ≥50 kg and who have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
Either male or female.

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Female subjects must have a negative pregnancy test result at screening and check-in and, on admission to the unit, must not be lactating.
Female subjects must be of non-childbearing potential, as confirmed at screening by fulfilling one of the following criteria:
Post-menopausal women must have had ≥12 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) concentration consistently ≥40 mIU/mL and must have a negative pregnancy test result at screening and check-in.
Surgically sterile women, defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), bilateral salpingectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report or relevant medical records, or by ultrasound, and must have a negative pregnancy test result at screening and check-in.
Male subjects must be vasectomized.

Who cannot join

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (American Psychiatric Association 2013) which, in the opinion of the Investigator, could be detrimental to subject safety or could compromise study data interpretation.
Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
Subjects who are undergoing treatment or evaluation for infertility.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of administration of Investigational Product.

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Any clinically important abnormalities noted at the screening assessments in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus antibodies.
Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
Systolic BP <90 mmHg or ≥140 mmHg.
Diastolic BP <50 mmHg or ≥90 mmHg.
HR <45 or >85 beats per minute.
Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG which, in the Investigator's opinion, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology.
ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) >450 ms or family history of long QT syndrome.
ECG interval measured from the onset of the P wave to the onset of the QRS complex (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), persistent or intermittent second (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 ECG interval measured from the onset of the QRS complex to the J point (QRS) >110 ms. Subjects with QRS >110 ms but <115 ms are acceptable if there is no evidence of, eg, ventricular hypertrophy or pre-excitation.
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 defined as an average weekly intake of >21 units or an average daily intake of >3 units for men or an average weekly intake of >14 units or an average daily intake of >2 units for women. One unit is equivalent to a half pint (250 mL) of beer, 1 measure (25 mL) of spirits, or 1 glass (125 mL) of wine. If a subject is currently diagnosed with abuse of or dependence on alcohol, the subject will not be allowed to enroll in the study, unless the alcohol abuse/dependence is in full (complete, not partial), sustained (>1 year) remission.
Positive screen for drugs of abuse at screening or admission to the unit or positive screen for alcohol at screening to the unit prior to administration of IP.
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 AZD4041.
Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.
Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the Investigator.
Use of drugs with enzyme inducing properties, such as St John's wort, within 3 weeks prior to administration of IP.
Use of any prescribed or nonprescribed 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 the 2 weeks prior to administration of IP or longer if the medication has a long half life.
Use of any prescribed or nonprescribed oral and topical inhibitors/inducers of CYP3A4 (including shampoo).
Use of hormone replacement therapy.
Subjects who have previously received AZD4041.
Has received another new chemical entity (defined as a compound that has not been approved for marketing) within 3 months of administration of IP 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. 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.
Judgement by the Investigator that the subject should not participate in the study if they have any ongoing or recent (ie, 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.
Subjects who cannot communicate reliably with the Investigator.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Austin, Texas, 78744
Research Site
Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official title: A Phase I Randomized, Double-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4041 Following Single Ascending Dose Administration to Healthy Volunteers

Conditions: Smoking Cessation
Being tested: AZD4041, Placebo
Keywords: Safety, Tolerability, Pharmacokinetics, Healthy Volunteers
Medical subject headings: Smoking Cessation

What participants receive

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

AZD4041Drug
Administration by Oral syringe
PlaceboDrug
Administration by Oral syringe

Study groups in NCT04076540
Study group	Role	What they receive
AZD4041	Experimental	Not described Receives: Drug: AZD4041
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Adverse Events
Number of participants experiencing any adverse event
Measured: 6 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants experiencing any treatment emergent adverse events
Measured: 6 weeks
Number of Participants With Treatment-Related TEAEs
Number of participants experiencing any treatment-related TEAEs
Measured: 6 weeks
Number of Participants With Moderate TEAEs
Number of participants experiencing any moderate TEAEs
Measured: 6 weeks
Number of Participants With Treatment-Related Moderate TEAEs
Number of participants experiencing any treatment-related moderate TEAEs
Measured: 6 weeks
Number of Participants With Severe TEAEs
Number of participants experiencing any severe TEAEs
Measured: 6 weeks
Number of Participants With Treatment-Related Severe TEAEs
Number of participants experiencing any treatment-related severe TEAEs
Measured: 6 weeks
Number of Participants With Serious Adverse Events (SAEs)
Number of participants experiencing any serious adverse events (SAEs)
Measured: 6 weeks
Number of Participants With Treatment-Related SAEs
Number of participants experiencing any treatment-related serious adverse events (SAEs)
Measured: 6 weeks
Number of Participants With TEAEs Leading to Early Discontinuation
Number of participants with treatment-emergent adverse events leading to early discontinuation
Measured: 6 weeks
Number of Participant Deaths
Number of participants who died
Measured: 6 weeks
Number of Participants With Abnormal Vital Signs
Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.
Measured: 6 weeks
Number of Participants With Abnormal Vital Signs (Blood Pressure)
Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 6 weeks
Number of Participants With Abnormal Vital Signs (Heart Rate)
Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 6 weeks
Pulse Rate at Baseline and Day 1 2 Hours Post.
Measured by standing pulse rate at baseline and 2 hours post
Measured: Baseline and Day 1
Number of Participants With Abnormal Safety Laboratory Tests (Hematology)
Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 6 weeks
Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)
Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 6 weeks
Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)
Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 6 weeks
Number of Participants With Abnormal 12-lead ECGs
Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: 4 days
Heart Rate at Baseline and Times Post Dose
Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Aggregate P-R Interval at Baseline and Time Post Dose
PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Aggregate QRS Complex at Baseline and Times Post Dose
QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Aggregate QT Interval at Baseline and Times Post Dose
The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Aggregate QTcF Interval and Times Post Dose
The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Aggregate RR Interval at Baseline and Times Post Dose
The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)
Measured: Thru Day 4
Number of Participants With Abnormal Testosterone Test Results
Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: Thru Day 4
Number of Participants With Abnormal Luteinizing Hormone Test Results
Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: Thru Day 4
Number of Participants With Abnormal Follicle Stimulating Hormone Test Results
Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: Thru Day 4
Number of Participants With Abnormal Inhibin B Test Results
Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured: Thru Day 4

Secondary outcomes (7)

Cmax of AZD4041
Maximum (peak) plasma concentration of AZD4041
Measured: Thru Day 4
Tmax of AZD4041
Time to reach maximum (peak) plasma concentration of AZD4041
Measured: Thru Day 4
AUC0-t
Area under the curve of AZD4041 from time 0 to time t (AUC from zero to the last measurable concentration)
Measured: Thru Day 4
AUC0-inf
Extrapolation of the area under the curve of AZD4041 from zero to infinity
Measured: Thru Day 4
t1/2λz
Terminal half-life of AZD4041
Measured: Thru Day 4
CL/F (Volume/Time)
Apparent total clearance of the AZD4041 from plasma
Measured: Thru Day 4
Vss/F (Plasma)
Apparent volume of distribution of AZD4041 at steady state
Measured: Thru Day 4

Timeline

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

3 Oct 20192 Jan 2022

First posted3 Sep 2019
Study start3 Oct 2019
Primary completion2 Jan 2022
Study completion2 Jan 2022

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 Smoking CessationStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04076540
Sponsor's protocol ID: D7460C00001
Status last verified: Jun 2024
First submitted: 6 Aug 2019
Last updated: 17 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Randomized, Double-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4041 Following Single Ascending Dose Administration to Healthy Volunteers
ClinicalTrials.gov ID: NCT04076540
Acronym / sponsor ID: D7460C00001
Conditions: Smoking Cessation
Keywords: Safety, Tolerability, Pharmacokinetics, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: National Institutes of Health (NIH), Eolas Therapeutics INC.
Study start: 3 Oct 2019 (actual)
Primary completion: 2 Jan 2022 (actual)
Study completion: 2 Jan 2022 (actual)
First posted: 3 Sep 2019 (actual)
Results: Posted 17 Jul 2024

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD4041	Experimental	Drug: AZD4041
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this clinical study protocol.
Provision of signed and dated, written Informed Consent Form prior to any mandatory study specific procedures, sampling, and analyses.
Subjects must be ≥18 and less than or equal to 65 years of age at the time of signing the Informed Consent Form.
Individuals who are healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
Individuals who weigh ≥50 kg and who have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.

Key exclusion criteria (34 listed)

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (American Psychiatric Association 2013) which, in the opinion of the Investigator, could be detrimental to subject safety or could compromise study data interpretation.
Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
Subjects who are undergoing treatment or evaluation for infertility.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.

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
AZD4041Administration by Oral syringe	Drug	AZD4041
PlaceboAdministration by Oral syringe	Drug	Placebo

Primary outcome

Number of Adverse Events
Time frame: 6 weeks
Number of participants experiencing any adverse event
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 6 weeks
Number of participants experiencing any treatment emergent adverse events
Number of Participants With Treatment-Related TEAEs
Time frame: 6 weeks
Number of participants experiencing any treatment-related TEAEs
Number of Participants With Moderate TEAEs
Time frame: 6 weeks
Number of participants experiencing any moderate TEAEs
Number of Participants With Treatment-Related Moderate TEAEs
Time frame: 6 weeks
Number of participants experiencing any treatment-related moderate TEAEs
Number of Participants With Severe TEAEs
Time frame: 6 weeks
Number of participants experiencing any severe TEAEs
Number of Participants With Treatment-Related Severe TEAEs
Time frame: 6 weeks
Number of participants experiencing any treatment-related severe TEAEs
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 6 weeks
Number of participants experiencing any serious adverse events (SAEs)
Number of Participants With Treatment-Related SAEs
Time frame: 6 weeks
Number of participants experiencing any treatment-related serious adverse events (SAEs)
Number of Participants With TEAEs Leading to Early Discontinuation
Time frame: 6 weeks
Number of participants with treatment-emergent adverse events leading to early discontinuation
Number of Participant Deaths
Time frame: 6 weeks
Number of participants who died
Number of Participants With Abnormal Vital Signs
Time frame: 6 weeks
Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.
Number of Participants With Abnormal Vital Signs (Blood Pressure)
Time frame: 6 weeks
Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Vital Signs (Heart Rate)
Time frame: 6 weeks
Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Pulse Rate at Baseline and Day 1 2 Hours Post.
Time frame: Baseline and Day 1
Measured by standing pulse rate at baseline and 2 hours post
Number of Participants With Abnormal Safety Laboratory Tests (Hematology)
Time frame: 6 weeks
Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)
Time frame: 6 weeks
Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)
Time frame: 6 weeks
Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal 12-lead ECGs
Time frame: 4 days
Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Heart Rate at Baseline and Times Post Dose
Time frame: Thru Day 4
Measured by digital electrocardiograms (ECGs)
Aggregate P-R Interval at Baseline and Time Post Dose
Time frame: Thru Day 4
PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Aggregate QRS Complex at Baseline and Times Post Dose
Time frame: Thru Day 4
QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Aggregate QT Interval at Baseline and Times Post Dose
Time frame: Thru Day 4
The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)
Aggregate QTcF Interval and Times Post Dose
Time frame: Thru Day 4
The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)
Aggregate RR Interval at Baseline and Times Post Dose
Time frame: Thru Day 4
The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)
Number of Participants With Abnormal Testosterone Test Results
Time frame: Thru Day 4
Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Luteinizing Hormone Test Results
Time frame: Thru Day 4
Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Follicle Stimulating Hormone Test Results
Time frame: Thru Day 4
Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of Participants With Abnormal Inhibin B Test Results
Time frame: Thru Day 4
Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

7 secondary outcomes

Cmax of AZD4041
Time frame: Thru Day 4
Tmax of AZD4041
Time frame: Thru Day 4
AUC0-t
Time frame: Thru Day 4
AUC0-inf
Time frame: Thru Day 4
t1/2λz
Time frame: Thru Day 4
CL/F (Volume/Time)
Time frame: Thru Day 4
Vss/F (Plasma)
Time frame: Thru Day 4

Results and safety

Results posted to the registry on 17 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pooled Placebo	2	2
AZD4041 X mg	6	6
AZD4041 3X mg	0	0
AZD4041 9X mg	0	0
AZD4041 20X mg	0	0
AZD4041 40X mg	0	0
AZD4041 80X mg	0	0

Primary outcome: Number of Adverse Events

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Pooled Placebo n = 12	AZD4041 X mg n = 6	AZD4041 3X mg n = 6	AZD4041 9X mg n = 6	AZD4041 20X mg n = 6	AZD4041 40X mg n = 6	AZD4041 80X mg n = 6
Value	5	0	1	1	1	3	1

Population analysed: Safety Analysis Set

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Pooled Placebo n = 12	AZD4041 X mg n = 6	AZD4041 3X mg n = 6	AZD4041 9X mg n = 6	AZD4041 20X mg n = 6	AZD4041 40X mg n = 6	AZD4041 80X mg n = 6
Value	5	0	1	1	1	3	1

Population analysed: Safety Analysis Set

Primary outcome: Number of Participants With Treatment-Related TEAEs

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Pooled Placebo n = 12	AZD4041 X mg n = 6	AZD4041 3X mg n = 6	AZD4041 9X mg n = 6	AZD4041 20X mg n = 6	AZD4041 40X mg n = 6	AZD4041 80X mg n = 6
Value	1	0	1	1	0	2	0

Population analysed: Safety Analysis Set

Primary outcome: Number of Participants With Moderate TEAEs

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Pooled Placebo n = 12	AZD4041 X mg n = 6	AZD4041 3X mg n = 6	AZD4041 9X mg n = 6	AZD4041 20X mg n = 6	AZD4041 40X mg n = 6	AZD4041 80X mg n = 6
Value	0	0	1	0	0	2	0

Population analysed: Safety Analysis Set

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled Placebo	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
AZD4041 X mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
AZD4041 3X mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
AZD4041 9X mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
AZD4041 20X mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
AZD4041 40X mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
AZD4041 80X mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Limitations and caveats (from the sponsor): Three participants (1 participant in AZD4041 20X mg and 2 participants in AZD4041 40X mg) had 7 important protocol deviations during the study under the category of study procedure and assessments. None were determined by the investigator and sponsor to affect participant safety or the analyses and outcomes of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

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.

Rebecca N. Wood-Horrall, MD principal investigator

PPD Development, LP

Darin Brimhall, DO, FACP principal investigator

PPD Development, LP

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD4041 in people with Smoking Cessation, run by AstraZeneca at 2 sites in United States.

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 11 inclusion and 34 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 17 Jul 2024). 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?

Number of Adverse Events (time frame: 6 weeks). The study lists 29 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 NCT04076540.

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 17 Jul 2024.