Type 1 Diabetes MellitusPhase 1NCT05248841
A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers
A Phase 1 study testing HEC-Glargine and US-Lantus in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Lannett Company, Inc. at 1 site in South Africa.
Trial summary
This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- HEC-Glargine and US-Lantus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Mar 2022to 31 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant has body weight not less than 60 kg and body mass index between 18.5 and 30.0 kg/m^2 (both inclusive).
- Glycohemoglobin (HbA1c) levels are <6.0%.
- Normal oral glucose tolerance test conducted within the previous 6 months
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations should be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests
- Non-smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).
Who cannot join
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Current alcohol use >21 units of alcohol per week
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies
- Participation in another study with an experimental drug, where the last administration of the previous study drug was within 12 weeks before administration of study drug in this study.
- Treatment within the previous 3 months before the first administration of study drug with any drug with a well-defined potential for adversely affecting a major organ or system.
Show all 17Show fewer
- A major disease (i.e., a disease that could not be treated at home, but the subject had to be hospitalized or needed general anesthesia usually for a major operation) during the 3 months before commencement of the screening period.
- Positive test for insulin antibodies.
- History of bronchial asthma or any other bronchospastic disease, and/or convulsions, and/or porphyria.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Resting pulse of >100 beats per minute (bpm) or <40 bpm during the screening period, either supine or standing.
- Hypertension diagnosed during screening or current diagnosis of hypertension.
- Hemoglobin count deviating more than 10% of the lower limit of normal.
- Clinically relevant abnormalities in the coagulation status.
- History of bleeding disorders.
- Veins unsuitable for venous blood collection and cannulation.
- Any specific study drug safety concern.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
FARMOVS Clinical Research Organization
Bloemfontein, Free State, 9301
About this study
Official title: A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers
This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.
Read the detailed description
This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence crossover clamp study performed at a single study center. The study population consists of healthy adult male subjects.
The study will comprise of:
- A screening period: maximum 28 days prior to first dose administration.
- Admission: Subjects will be admitted to the study center on Day -1
- Two Treatment Periods (Treatment Periods 1 and 2): Subjects will be randomized to either of the 2 treatment sequences (AB or BA) on Day 1 of Treatment Period 1 to receive either test or reference product as per randomization schedule in a 1:1 ratio.
- Treatment A (Test Formulation): HEC-Glargine
- Treatment B (Reference Formulation): US-Lantus®
On Day 1 of each Treatment Period, the study drug or reference product will be administered as a single morning dose to subjects in a fasting state. There will be a wash-out period of at least 7 calendar days. Each subject will receive both test and reference products in a crossover pattern over Treatment Periods 1 and 2.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- HEC-Glargine, US-Lantus
- Keywords
- pharmacokinetic, pharmacodynamic, euglycemic clamp technique, insulin glargine, biosimilarity study
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC-GlargineDrug
Subjects will receive 0.5 IU/kg of HEC-Glargine subcutaneously as a single morning dose on Day 1.
US-LantusDrug
Also called Insulin glargine
Subjects will receive 0.5 IU/kg of Lantus subcutaneously as a single morning dose on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| HEC-Glargine Treatment A (Test) | Experimental | Subjects will receive single doses of Test Formulation HEC-Glargine on Day 1 of Treatment periods 1 and 2 followed by at least 7-21 days washout. Receives: Drug: HEC-Glargine |
| US-Lantus Treatment B (Reference) | Active comparator | Subjects will receive single doses of Reference Formulation Lantus on Day 1 followed of Treatment periods 1 and 2 by at least 7-21 days washout. Receives: Drug: US-Lantus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from 0 hours to 24 hours (AUC0-24h) of M1
The Pharmacokinetics (PK) parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.
Measured: Day 1 and Day 2
Maximum observed plasma exogenous insulin glargine concentration (Cmax) of M1
The PK parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.
Measured: Day 1 and Day 2
Area under the Glucose infusion rate (GIR) -time curve (calculated as the exact area under the stepwise constant function) from 0 hours to 24 hours (GIRAUC0-24h)
The pharmacodynamics (PD) of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.
Measured: Day 1 and Day 2
Maximum GIR (GIRmax)
The PD of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.
Measured: Day 1 and Day 2
Secondary outcomes (24)
Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time (AUC0-t)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed. Also, AUC0-t will be evaluating the inter-subject and intra-subject variability of PK of HEC-Glargine in comparison to US-Lantus®, assessed by intra-subject coefficients of variation for primary PK parameters.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to 6 hours (AUC0-6h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 6 hours to 12 hours (AUC6-12h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to 12 hours (AUC0-12h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 12 hours to 18 hours (AUC12-18h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 18 hours to 24 hours (AUC18-24h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 12 hours to 24 hours (AUC12-24h)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Time to maximum plasma exogenous insulin glargine concentration (Tmax)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time extrapolated to infinity (AUC0-∞)
The PK parameters of HEC-Glargine, US-Lantus®, and M1 will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve for the time of a dosing interval (GIRAU0-t)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed. Also, GIRAU0-t will be evaluating the inter-subject and intra-subject variability of PD of HEC-Glargine in comparison to US-Lantus®, assessed by intra-subject coefficients of variation for primary PD parameters.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to end of clamp (GIRAUC0-end of clamp)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to the last quantifiable concentration-time with extrapolation to infinity (GIRAUC0-∞)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to 6 hours (GIRAUC0-6h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 6 hours to 12 hours (GIRAUC6-12h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to 12 hours (GIRAUC0-12h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 12 hours to18 hours (GIRAUC12-18h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 18 hours to 24 hours (GIRAUC18-24h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Area under the GIR-time curve from 12 hours to 24 hours (GIRAUC12-24h)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Time to maximum glucose infusion rate (TGIRmax)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Total amount of glucose infused during clamp procedure (Gtot)
The PD parameters of HEC-Glargine, US-Lantus® will be assessed.
Measured: Day 1 and Day 2
Time to onset of action (TOA)
The TOA will be assessed for HEC-Glargine, US-Lantus® as PD parameters.
Measured: Day 1 and Day 2
Maximum observed plasma exogenous insulin glargine concentration (Cmax)
The Cmax will be evaluating the inter-subject and intra-subject variability of PK of HEC-Glargine in comparison to US-Lantus®, assessed by intra-subject coefficients of variation for primary PK parameters.
Measured: Day 1 and Day 2
Maximum GIR (GIRmax)
The GIRmax will be evaluating the inter-subject and intra-subject variability of PD of HEC-Glargine in comparison to US-Lantus®, assessed by intra-subject coefficients of variation for primary PD parameters.
Measured: Day 1 and Day 2
Number of subjects with adverse events (AEs)
To assess safety and tolerability of the HEC-Glargine compared to US-Lantus® after single SC dose To assess safety and tolerability of the HEC-Glargine compared to US-Lantus® after single SC dose
Measured: Day -1 to within 7 Days of completion of the last period or early withdrawal (approximately 31 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start8 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lannett Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, FARMOVS (Pty) Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248841
- Sponsor's protocol ID
- LC-INS-2001
- Other IDs
- PIND147873
- Status last verified
- Sep 2022
- First submitted
- 24 Jan 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers
- ClinicalTrials.gov ID
- NCT05248841
- Acronym / sponsor ID
- LC-INS-2001
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- pharmacokinetic, pharmacodynamic, euglycemic clamp technique, insulin glargine, biosimilarity study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Lannett Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel, FARMOVS (Pty) Ltd
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.
Detailed description
This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence crossover clamp study performed at a single study center. The study population consists of healthy adult male subjects.
The study will comprise of:
- A screening period: maximum 28 days prior to first dose administration.
- Admission: Subjects will be admitted to the study center on Day -1
- Two Treatment Periods (Treatment Periods 1 and 2): Subjects will be randomized to either of the 2 treatment sequences (AB or BA) on Day 1 of Treatment Period 1 to receive either test or reference product as per randomization schedule in a 1:1 ratio.
- Treatment A (Test Formulation): HEC-Glargine
- Treatment B (Reference Formulation): US-Lantus®
On Day 1 of each Treatment Period, the study drug or reference product will be administered as a single morning dose to subjects in a fasting state. There will be a wash-out period of at least 7 calendar days. Each subject will receive both test and reference products in a crossover pattern over Treatment Periods 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEC-Glargine Treatment A (Test) | Experimental | Drug: HEC-GlargineSubjects will receive single doses of Test Formulation HEC-Glargine on Day 1 of Treatment periods 1 and 2 followed by at least 7-21 days washout. |
| US-Lantus Treatment B (Reference) | Active comparator | Drug: US-LantusSubjects will receive single doses of Reference Formulation Lantus on Day 1 followed of Treatment periods 1 and 2 by at least 7-21 days washout. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant has body weight not less than 60 kg and body mass index between 18.5 and 30.0 kg/m^2 (both inclusive).
- Glycohemoglobin (HbA1c) levels are <6.0%.
- Normal oral glucose tolerance test conducted within the previous 6 months
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations should be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests
- Non-smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).
Key exclusion criteria (17 listed)
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Current alcohol use >21 units of alcohol per week
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies
- Participation in another study with an experimental drug, where the last administration of the previous study drug was within 12 weeks before administration of study drug in this study.
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 |
|---|---|---|
| HEC-GlargineSubjects will receive 0.5 IU/kg of HEC-Glargine subcutaneously as a single morning dose on Day 1. | Drug | HEC-Glargine Treatment A (Test) |
| US-LantusAlso: Insulin glargineSubjects will receive 0.5 IU/kg of Lantus subcutaneously as a single morning dose on Day 1. | Drug | US-Lantus Treatment B (Reference) |
Primary outcome
Area under the concentration-time curve from 0 hours to 24 hours (AUC0-24h) of M1
Time frame: Day 1 and Day 2
The Pharmacokinetics (PK) parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.
Maximum observed plasma exogenous insulin glargine concentration (Cmax) of M1
Time frame: Day 1 and Day 2
The PK parameters of HEC-Glargine to the US-approved Lantus® insulin glargine injection (US-Lantus®) solution for SC injection to demonstrate PK similarity for insulin glargine and/or metabolite 21A-Gly-human insulin (M1) will be assessed.
Area under the Glucose infusion rate (GIR) -time curve (calculated as the exact area under the stepwise constant function) from 0 hours to 24 hours (GIRAUC0-24h)
Time frame: Day 1 and Day 2
The pharmacodynamics (PD) of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.
Maximum GIR (GIRmax)
Time frame: Day 1 and Day 2
The PD of HEC-Glargine to US-Lantus®, by means of GIR profiles after single SC dose will be assessed.
24 secondary outcomes
Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time (AUC0-t)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to 6 hours (AUC0-6h)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 6 hours to 12 hours (AUC6-12h)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to 12 hours (AUC0-12h)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 12 hours to 18 hours (AUC12-18h)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 18 hours to 24 hours (AUC18-24h)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 12 hours to 24 hours (AUC12-24h)
Time frame: Day 1 and Day 2
Time to maximum plasma exogenous insulin glargine concentration (Tmax)
Time frame: Day 1 and Day 2
Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time extrapolated to infinity (AUC0-∞)
Time frame: Day 1 and Day 2
Area under the GIR-time curve for the time of a dosing interval (GIRAU0-t)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to end of clamp (GIRAUC0-end of clamp)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to the last quantifiable concentration-time with extrapolation to infinity (GIRAUC0-∞)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to 6 hours (GIRAUC0-6h)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 6 hours to 12 hours (GIRAUC6-12h)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 0 hours to 12 hours (GIRAUC0-12h)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 12 hours to18 hours (GIRAUC12-18h)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 18 hours to 24 hours (GIRAUC18-24h)
Time frame: Day 1 and Day 2
Area under the GIR-time curve from 12 hours to 24 hours (GIRAUC12-24h)
Time frame: Day 1 and Day 2
Time to maximum glucose infusion rate (TGIRmax)
Time frame: Day 1 and Day 2
Total amount of glucose infused during clamp procedure (Gtot)
Time frame: Day 1 and Day 2
Time to onset of action (TOA)
Time frame: Day 1 and Day 2
Maximum observed plasma exogenous insulin glargine concentration (Cmax)
Time frame: Day 1 and Day 2
Maximum GIR (GIRmax)
Time frame: Day 1 and Day 2
Number of subjects with adverse events (AEs)
Time frame: Day -1 to within 7 Days of completion of the last period or early withdrawal (approximately 31 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 HEC-Glargine and US-Lantus in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Lannett Company, Inc. at 1 site in South Africa.
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 5 inclusion and 17 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 15 Sep 2022. 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 South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the concentration-time curve from 0 hours to 24 hours (AUC0-24h) of M1 (time frame: Day 1 and Day 2). The study lists 4 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 15 Sep 2022.