Nicotine VapingNCT05383508

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

A study testing CA35, CM35 and Cig in people with Nicotine Vaping and Nicotine, run by Philip Morris Products S.A. at 1 site in United States.

Completed

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

Official record

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Trial summary

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. Read more about this study

Who is it for?: Ages 24 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Vaping, Nicotine, Vaping
What is being tested?: CA35, CM35 and Cig
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 28 Apr 2022to 25 Aug 2022
Phase: Interventional
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 24 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject has signed the ICF and is able to understand the information provided in the ICF.
Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Who cannot join

As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
BMI < 18.5 kg/m2 or > 35.0 kg/m2.
Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.
Subject has a history of alcohol abuse that could interfere with the subject's participation in study.

Show all 11Show fewer

Subject has a positive urine drug test.
Subject has a positive alcohol breath test.
Subject has participated in another clinical study within 30 days prior to the Screening Visit.
Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is breastfeeding.
For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site

High Point Clinical Trials Center (HPCTC)
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes

In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design.

This study is exploratory and there is no pre-specified hypothesis to be tested.

Read the detailed description

The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study.

The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

Conditions: Nicotine Vaping, Nicotine, Vaping
Being tested: CA35, CM35, Cig
Keywords: Nicotine, Pharmacokinetics, Smoking, Cigarette, E-Cigarette
Medical subject headings: Vaping, Smoking

What participants receive

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

CA35Other
Also called P4M3 variant CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35Other
Also called P4M3 variant CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
CigOther
Subjects' preferred brand of commercially available, regular or mentholated cigarettes

Study groups in NCT05383508
Study group	Role	What they receive
Product Sequence 1	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; Cig on Day 2; CM35 on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig
Product Sequence 2	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; CM35 on Day 2; Cig on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig
Product Sequence 3	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CA35 on Day 2; CM35 on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig
Product Sequence 4	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CM35 on Day 2; CA35 on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig
Product Sequence 5	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; Cig on Day 2; CA35 on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig
Product Sequence 6	Active comparator	After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; CA35 on Day 2; Cig on Day 3 Receives: Other: CA35; Other: CM35; Other: Cig

What is being measured

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

Background-corrected Maximum Plasma Concentration [Cmax]
To measure Cmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Measured: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Background-corrected Time to the Maximum Concentration [Tmax]
To measure Tmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Measured: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Measured: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Maximum Ratio of Background-corrected Concentration Over Time
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Measured: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)

Timeline

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

28 Apr 202225 Aug 2022

First posted20 May 2022
Study start28 Apr 2022
Primary completion29 Jun 2022
Study completion25 Aug 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 Nicotine VapingStudies 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 N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05383508
Sponsor's protocol ID: P4-PK-04-US
Status last verified: Apr 2024
First submitted: 17 May 2022
Last updated: 26 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nicotine Vaping trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes
ClinicalTrials.gov ID: NCT05383508
Acronym / sponsor ID: P4-PK-04-US
Conditions: Nicotine Vaping, Nicotine, Vaping
Keywords: Nicotine, Pharmacokinetics, Smoking, Cigarette, E-Cigarette
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 28 Apr 2022 (actual)
Primary completion: 29 Jun 2022 (actual)
Study completion: 25 Aug 2022 (actual)
First posted: 20 May 2022 (actual)
Results: Posted 26 Apr 2024

Clinical summary

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

This study is exploratory and there is no pre-specified hypothesis to be tested.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Product Sequence 1	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; Cig on Day 2; CM35 on Day 3
Product Sequence 2	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; CM35 on Day 2; Cig on Day 3
Product Sequence 3	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CA35 on Day 2; CM35 on Day 3
Product Sequence 4	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CM35 on Day 2; CA35 on Day 3
Product Sequence 5	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; Cig on Day 2; CA35 on Day 3
Product Sequence 6	Active comparator	Other: CA35, Other: CM35, Other: CigAfter at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; CA35 on Day 2; Cig on Day 3

Who may qualify

Ages: 24 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject has signed the ICF and is able to understand the information provided in the ICF.
Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Key exclusion criteria (11 listed)

As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
BMI < 18.5 kg/m2 or > 35.0 kg/m2.
Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.

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
CA35Also: P4M3 variant CA35Nicotine concentration: 3.5 % e-liquid flavor: Tobacco	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6
CM35Also: P4M3 variant CM35Nicotine concentration: 3.5 % e-liquid flavor: Menthol	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6
CigSubjects' preferred brand of commercially available, regular or mentholated cigarettes	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6

Primary outcome

Background-corrected Maximum Plasma Concentration [Cmax]
Time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
To measure Cmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Background-corrected Time to the Maximum Concentration [Tmax]
Time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
To measure Tmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.
Time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Maximum Ratio of Background-corrected Concentration Over Time
Time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)

Results and safety

Results posted to the registry on 26 Apr 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
Product Sequence 1	6	5
Product Sequence 2	6	6
Product Sequence 3	6	5
Product Sequence 4	6	5
Product Sequence 5	6	4
Product Sequence 6	6	6

Primary outcome: Background-corrected Maximum Plasma Concentration [Cmax]

Time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.). Geometric mean (95% Confidence Interval). Unit: (ng/mL)

Measure	CA35 n = 22	CM35 n = 23	Cigarettes n = 23
Value	2.934 (1.695 to 5.080)	3.365 (1.919 to 5.900)	17.49 (12.29 to 24.89)

CA35 vs Cigarettes: Geometric LS Mean Ratio (%): 17.05 (95% CI 10.69 to 27.19), Mixed Models Analysis
CM35 vs Cigarettes: Geometric LS Mean Ratio (%): 19.47 (95% CI 11.89 to 31.87), Mixed Models Analysis

Population analysed: The analysis population was a subset of the Safety Population and consisted of all randomized subjects, without major protocol deviations, for whom at least one nicotine PK parameter could be derived.

Primary outcome: Background-corrected Time to the Maximum Concentration [Tmax]

Measure	CA35 n = 22	CM35 n = 23	Cigarettes n = 23
Value	109.3 (-33.28 to 251.8)	37.79 (-15.62 to 91.21)	7.826 (6.926 to 8.726)

CA35 vs Cigarettes: Median Difference (Net): 3.000 (95% CI 0.00 to 11.00), Wilcoxon signed rank test
CM35 vs Cigarettes: Mean Difference (Net): 2.000 (95% CI 0.00 to 4.00), Wilcoxon signed rank test

Primary outcome: Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.

Measure	CA35 n = 14	CM35 n = 14	Cigarettes n = 19
Value	891.1 (515.6 to 1540)	655.6 (317.0 to 1356)	2484 (1880 to 3283)

CA35 vs Cigarettes: Geometric LS Mean Ratio (%): 28.29 (95% CI 16.00 to 50.04), Mixed Models Analysis
CM35 vs Cigarettes: Geometric LS Mean Ratio (%): 26.16 (95% CI 12.74 to 53.69), Mixed Models Analysis

Primary outcome: Maximum Ratio of Background-corrected Concentration Over Time

Measure	CA35 n = 22	CM35 n = 23	Cigarettes n = 23
Value	0.3547 (0.1618 to 0.7777)	0.5150 (0.2760 to 0.9610)	3.239 (2.277 to 4.608)

CA35 vs Cigarettes: Geometric LS Mean Ratio (%): 10.84 (95% CI 5.57 to 21.10), Mixed Models Analysis
CM35 vs Cigarettes: Geometric LS Mean Ratio (%): 16.83 (95% CI 9.93 to 28.53), Mixed Models Analysis

Adverse events

Time frame: Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 34 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population (CA35 Test)	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Safety Population (CA35)	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Safety Population (CM35)	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Cigarettes	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Melanie Fein, MD principal investigator

High Point Clinical Trials Center (HPCTC)

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

Questions about this trial

What is this clinical trial studying?

A study testing CA35, CM35 and Cig in people with Nicotine Vaping and Nicotine, run by Philip Morris Products S.A. at 1 site 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 5 inclusion and 11 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 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?

Background-corrected Maximum Plasma Concentration [Cmax] (time frame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)). 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?

On the ClinicalTrials.gov record for NCT05383508.

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 26 Apr 2024.