Healthy VolunteerPhase 1NCT04976855
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
A Phase 1 study testing INDV-2000 and SUBOXONE® sublingual film in people with Healthy Volunteer and Opioid-use Disorder, run by Indivior Inc. at 3 sites in United States.
Trial summary
The primary objectives for the study are: Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Opioid-use Disorder
- What is being tested?
- INDV-2000 and SUBOXONE® sublingual film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2022to 5 Jul 2023
- 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
- Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
- Female subjects of child-bearing potential who are sexually active with males must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 30 days after the last dose of Investigational Medicinal Product (IMP). The impact of IMP on the efficacy of hormonal contraceptives is unknown. Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of IMP and agree to not donate sperm over this time period. Effective methods of contraception are:
- Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception: oral, injectable/implantable, or intrauterine hormone-releasing system (IUD)
- Implantable intrauterine device (IUS)
- Surgical sterilization (for example, vasectomy or bilateral tubal ligation)
Show all 16Show fewer
- Male condom with spermicidal gel/foam or with female cap or diaphragm (double barrier)
- abstinence from heterosexual intercourse as a conscious choice and established pattern of lifestyle
- Part I and II only:
- Healthy male or female.
- Between 18 and 55 years of age inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).
- Part III only:
- Male or female seeking treatment for OUD with a diagnosis of moderate or severe OUD by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Between 18 and 65 years of age inclusive.
- BMI within 18.0 to 35.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).
Who cannot join
- Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.
- Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator or medically responsible physician.
- Have a history of narcolepsy or other significant sleep disorders.
- Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes.
- Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
- Serious cardiac illness or other cardiac assessments including, but not limited to:
Show all 40Show fewer
- Uncontrolled arrhythmias.
- History of congestive heart failure (CHF).
- Myocardial infarction <6 months from receipt of first dose of IMP
- Uncontrolled symptomatic angina
- QTcF > 450 msec for males and > 470 msec for females or history of prolonged QT syndrome.
- Current active hepatic or biliary disease, including subjects with cholecystectomy <90 days prior to Screening.
- Concurrent treatment or treatment with an investigational drug within 30 days prior to the first dose of any study drug.
- History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
- Pregnant or lactating females.
- Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges within 7 days prior to the IMP administration.
- Treatment with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) 3A4 within 30 days prior to first dose of IMP.
- Known allergy or hypersensitivity to IMP or its excipients.
- Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of subject safety or study results.
- Affiliated with, or a family member of, site staff directly involved in the study, or anyone with a financial interest in the outcome of the study.
- Subjects who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements.
- Participation in any other clinical study within 30 days prior to signing the informed consent form.
- Current incarceration or pending incarceration/legal action that could prevent participation or compliance in the study.
- Part I and II only:
- Regular alcohol consumption in males > 21 units per week and females > 14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Positive test result for alcohol and/or any drugs of abuse at screening
- Have a blood pressure reading outside of the following range: Systolic < 86 or > 149 mmHg; Diastolic < 50 or > 94 mmHg
- Current smokers and those who have smoked within the last 90 days. Current users of e-cigarettes and nicotine replacement products, and those who have used these products within the last 90 days.
- Blood donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (<11 g/dL for females, <12 g/dL for males).
- Healthy volunteers who are taking, or have taken, any prescribed or over-the-counter drugs (other than 2 g per day acetaminophen, hormone replacement therapy [HRT], hormonal contraception) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study, as agreed by an Investigator and Sponsor's Medical Monitor.
- Part III only:
- Regular alcohol consumption in males > 27 units per week and females > 20 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Current substance use disorder, as defined by DSM-5 criteria, with any substances other than opioids, tobacco, cannabis, or alcohol, or dependence with any substance that would interfere with the completion of the study by judgment of the Investigator or medically responsible physician.
- Current history of alcohol withdrawal within one year prior to screening.
- Blood donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (< 10 g/dL for females, < 12 g/dL for males).
- Have a blood pressure reading outside of the following range: Systolic < 86 or > 159 mmHg; Diastolic < 50 or > 99 mmHg. Investigator should rule out acute changes resulting from opioid withdrawal.
- Has total bilirubin ≥ 1.5 × upper limit of normal (ULN) (with direct bilirubin > 1.3 mg/dL), alanine aminotransferase (ALT) ≥ 3 × ULN, aspartate aminotransferase (AST) ≥ 3 × ULN, serum creatinine > 2 × ULN, or international normalized ratio (INR) > 1.5 × ULN at Screening).
- Received medication-assisted treatment for OUD (e.g., methadone, buprenorphine) in the 30 days prior to providing written informed consent.
- Received any prior treatment with a buprenorphine implant or injection.
- Treatment for OUD required by court order.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University School of Medicine BPRU
Baltimore, Maryland, 21224
InSite Clinical Research
DeSoto, Texas, 75115
Worldwide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder
The primary objectives for the study are:
- Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers.
- Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
Read the detailed description
The study will be conducted in 3 parts:
Part I: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers.
Part II: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers.
Part III: This part is an open-label study in OUD treatment seeking individuals.
- Conditions
- Healthy Volunteer, Opioid-use Disorder
- Being tested
- INDV-2000, Placebo, SUBOXONE® sublingual film
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INDV-2000Drug
Also called C4X_3256
Capsule for oral administration
PlaceboDrug
Capsule for oral administration
SUBOXONE® sublingual filmDrug
Also called Buprenorphine and naloxone
Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
| Study group | Role | What they receive |
|---|---|---|
| Part I Cohort 1 INDV-2000 100 mg QD | Experimental | Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days. Receives: Drug: INDV-2000 |
| Part I Cohort 1 Placebo | Placebo comparator | Healthy volunteers will receive placebo once daily for 7 days. Receives: Drug: Placebo |
| Part I Cohort 2 INDV-2000 100 mg BID | Experimental | Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days. Receives: Drug: INDV-2000 |
| Part I Cohort 2 Placebo | Placebo comparator | Healthy volunteers will receive placebo twice daily for 7 days. Receives: Drug: Placebo |
| Part II Cohort 1 INDV-2000 200 mg BID | Experimental | Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days. Receives: Drug: INDV-2000 |
| Part II Cohort 1 Placebo | Placebo comparator | Healthy volunteers will receive placebo twice daily for 28 days. Receives: Drug: Placebo |
| Part II Cohort 2 INDV-2000 400 mg BID | Experimental | Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days. Receives: Drug: INDV-2000 |
| Part II Cohort 2 Placebo | Placebo comparator | Healthy volunteers will receive placebo twice daily for 28 days. Receives: Drug: Placebo |
| Part III INDV-2000 400 mg BID + SUBOXONE SL Film | Experimental | Participants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days. Receives: Drug: INDV-2000; Drug: SUBOXONE® sublingual film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I and Part II: Number of Participants With Adverse Events
Measured: From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II).
Part III: Number of Participants With Adverse Events
Measured: From first dose of INDV-2000 up to 7 days after last dose (up to 18 days).
Secondary outcomes (3)
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 28 is only for Part II.
Measured: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 28 is only for Part II
Measured: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
τ = 12 hours for BID dosing and 24 hours for QD dosing. Day 28 is only for Part II.
Measured: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start17 Aug 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
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 Healthy VolunteerStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976855
- Sponsor's protocol ID
- INDV-2000-102
- Other IDs
- UG3DA050308
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2021
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04976855
- Acronym / sponsor ID
- INDV-2000-102
- Conditions
- Healthy Volunteer, Opioid-use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Posted 21 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives for the study are:
- Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers.
- Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
Detailed description
The study will be conducted in 3 parts:
Part I: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers.
Part II: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers.
Part III: This part is an open-label study in OUD treatment seeking individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part I Cohort 1 INDV-2000 100 mg QD | Experimental | Drug: INDV-2000Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days. |
| Part I Cohort 1 Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive placebo once daily for 7 days. |
| Part I Cohort 2 INDV-2000 100 mg BID | Experimental | Drug: INDV-2000Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days. |
| Part I Cohort 2 Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive placebo twice daily for 7 days. |
| Part II Cohort 1 INDV-2000 200 mg BID | Experimental | Drug: INDV-2000Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days. |
| Part II Cohort 1 Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive placebo twice daily for 28 days. |
| Part II Cohort 2 INDV-2000 400 mg BID | Experimental | Drug: INDV-2000Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days. |
| Part II Cohort 2 Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive placebo twice daily for 28 days. |
| Part III INDV-2000 400 mg BID + SUBOXONE SL Film | Experimental | Drug: INDV-2000, Drug: SUBOXONE® sublingual filmParticipants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
- Female subjects of child-bearing potential who are sexually active with males must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 30 days after the last dose of Investigational Medicinal Product (IMP). The impact of IMP on the efficacy of hormonal contraceptives is unknown. Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of IMP and agree to not donate sperm over this time period. Effective methods of contraception are:
- Healthy male or female.
- Between 18 and 55 years of age inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).
Key exclusion criteria (40 listed)
- Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.
- Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator or medically responsible physician.
- Have a history of narcolepsy or other significant sleep disorders.
- Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes.
- Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
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 |
|---|---|---|
| INDV-2000Also: C4X_3256Capsule for oral administration | Drug | Part I Cohort 1 INDV-2000 100 mg QD, Part I Cohort 2 INDV-2000 100 mg BID, Part II Cohort 1 INDV-2000 200 mg BID, Part II Cohort 2 INDV-2000 400 mg BID, Part III INDV-2000 400 mg BID + SUBOXONE SL Film |
| PlaceboCapsule for oral administration | Drug | Part I Cohort 1 Placebo, Part I Cohort 2 Placebo, Part II Cohort 1 Placebo, Part II Cohort 2 Placebo |
| SUBOXONE® sublingual filmAlso: Buprenorphine and naloxoneAdministered either under the tongue (sublingual) or between the gum and cheek (buccal) | Drug | Part III INDV-2000 400 mg BID + SUBOXONE SL Film |
Primary outcome
Part I and Part II: Number of Participants With Adverse Events
Time frame: From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II).
Part III: Number of Participants With Adverse Events
Time frame: From first dose of INDV-2000 up to 7 days after last dose (up to 18 days).
3 secondary outcomes
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Time frame: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Time frame: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Time frame: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 INDV-2000 and SUBOXONE® sublingual film in people with Healthy Volunteer and Opioid-use Disorder, run by Indivior Inc. at 3 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 16 inclusion and 40 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 21 Aug 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?
Part I and Part II: Number of Participants With Adverse Events (time frame: From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.