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Cohort 2: AZD4041 Dose Level 2 for Opioid Use Disorder

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose; day 14: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Awards & highlights

Study Summary

This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants. The study will include up to 48 participants (12 participants per cohort) who will be randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a MAD study. A sequential cohort MAD design will be employed to assure that higher doses are administered to healthy participants only after lower doses have demonstrated an acceptable safety profile. The total study duration will be up to 59 days (including Screening) per participant.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose; day 14: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose; day 14: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Number of Participants With Abnormal Male Hormone Levels as Assessed by the Investigator
+4 more
Secondary outcome measures
Accumulation Ratio Evaluated by Comparing Day 14 AUCτ to Day 1 AUC0-24 (RAC[AUC]) of AZD4041
Accumulation Ratio Evaluated by Comparing Day 14 Cmax to Day 1 Cmax (RAC[Cmax]) of AZD4041
Amount of AZD4041 Excreted Unchanged in Urine Over the 24-hour Dosing Interval (Ae0-24) After Day 1 Dose
+27 more

Side effects data

From 2022 Phase 1 trial • 36 Patients • NCT05233085
33%
Post lumbar puncture syndrome
33%
Medical device site reaction
22%
Headache
11%
Eye pain
11%
Eye pruritus
11%
Nasal congestion
11%
Lip dry
11%
Lacrimation increased
11%
Ocular hyperaemia
11%
Muscle spasms
11%
Nausea
11%
Back pain
11%
Ventricular tachycardia
11%
Hypoacusis
11%
Tinnitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohorts 1-3: Pooled Placebo
Cohort 3: AZD4041 Dose Level 3
Cohort 1: AZD4041 Dose Level 1
Cohort 2: AZD4041 Dose Level 2

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3: AZD4041 Dose Level 3Experimental Treatment1 Intervention
Participants will receive oral solution of AZD4041 dose level 3 QD directly into the mouth using a syringe from Days 1 to 14.
Group II: Cohort 2: AZD4041 Dose Level 2Experimental Treatment1 Intervention
Participants will receive oral solution of AZD4041 dose level 2 QD directly into the mouth using a syringe from Days 1 to 14.
Group III: Cohort 1: AZD4041 Dose Level 1Experimental Treatment1 Intervention
Participants will receive oral solution of AZD4041 dose level 1 once daily (QD) directly into the mouth using a syringe from Days 1 to 14.
Group IV: Cohorts 1-3: Pooled PlaceboPlacebo Group1 Intervention
Participants will receive oral solution of placebo equivalent to AZD4041 volume QD directly into the mouth using a syringe from Days 1 to 14.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4041
2021
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Altasciences Company Inc.Industry Sponsor
11 Previous Clinical Trials
411 Total Patients Enrolled
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,866 Total Patients Enrolled
Altasciences Company, Inc.Industry Sponsor
6 Previous Clinical Trials
212 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Safety Study of AZD4041 in Healthy Participants
2021. "A Safety Study of AZD4041 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233085.
~11 spots leftby Apr 2025
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