Healthy VolunteersPhase 1NCT05852340

A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

A Phase 1 study testing Ritlecitinib in people with Healthy Volunteers and Adult, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults. This study is seeking participants who are: aged 18 or older; male or female who are healthy as determined by medical assessment ; Body-mass Index (BMI) of 16 to 32, and a total body… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Adult, Pharmacokinetics
What is being tested?: Ritlecitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 9 May 2023to 24 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 18 or older.
Male or female who are healthy as determined by medical assessment.
Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

Who cannot join

Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency, or infections (acute or chronic).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) SPRINKLED IN APPLESAUCE, YOGHURT AND STRAWBERRY JAM RELATIVE TO INTACT BLEND-IN CAPSULE OF RITLECITINIB AND THE EFFECT OF FOOD ON THE BIOAVAILABILITY OF THE INTACT BLEND-IN CAPSULE DOSAGE FORMULATION OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.

This study is seeking participants who are:

aged 18 or older;
male or female who are healthy as determined by medical assessment ;
Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

The study will take up to 2.5 months, including the screening period. There will be 5 periods in total for this study. Participants will have to stay at the study clinic for at least 11 days. Participants will take Riltecitinib either as sprinkled in Soft Food or as Intact Blend-In Capsule. On day 1 of each period, participants will take Riltecitinib and have blood samples taken both before and afterwards. Participants will also answer questions for taste assessment purpose. A follow-up phone call will be made at 28 to 35 days after the last study period.

Read the detailed description

Ritlecitinib is a covalent and irreversible inhibitor of JAK3 with high selectivity over the other JAK isoforms (JAK1, JAK2, and TYK2). Ritlecitinib also inhibits irreversibly the tyrosine kinase expressed in TEC family kinases with selectivity over the broader human kinome. Treatment with ritlecitinib is expected to inhibit the inflammatory pathways mediated by IL 7, IL 15 and IL 21, all implicated in UC, CD, AA, RA, and vitiligo. Moreover, due to lack of activity against the other JAK isoforms, ritlecitinib is expected to spare immunoregulatory cytokines such as IL 10, IL 27 and IL 35, which are critical to the maintenance of immunosuppressive functions and immune homeostasis.

The objective of this study is to estimate the impact of administration methods on the bioavailability of the pediatric ritlecitinib intact BiC formulation. The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-crossover periods and 1-fixed period design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment. Blood samples will be collected for PK analysis. A taste assessment will be also conducted.

Participants will participate in the study for up to approximately 2.5 months, with the inclusion of the screening and follow-up period. On Day 1 of each period, participants will receive a single dose of IP. Administration of IP will be via dosing using intact BiCs with water or by emptying the capsule contents on soft food as per dosing instructions.

Participants will be confined in the CRU for a total of at least 11 days and discharged at the discretion of the investigator. A follow-up phone call will be made at least 28 calendar days and up to 35 calendar days after the last administration of the study intervention to capture any potential AE and confirm appropriate contraceptive usage.

Tolerability and safety will be assessed for all treatments by monitoring AEs.

Conditions: Healthy Volunteers, Adult, Pharmacokinetics
Being tested: Ritlecitinib
Keywords: Adult, Pharmacokinetic

What participants receive

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

RitlecitinibDrug
Also called PF-06651600
ritlecitinib 1 x 30 mg intact BiC (Treatment Arms A, E)
ritlecitinib 1 x 30 mg intact BiC sprinkled on soft foods (Treatment Arms B, C, D)

Study groups in NCT05852340
Study group	Role	What they receive
Treatment A	Active comparator	ritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state Receives: Drug: Ritlecitinib
Treatment B	Active comparator	contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state Receives: Drug: Ritlecitinib
Treatment C	Active comparator	contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state Receives: Drug: Ritlecitinib
Treatment D	Active comparator	contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state Receives: Drug: Ritlecitinib
Treatment E	Active comparator	ritlecitinib 1 x 30 mg intact BiC given with high fat meal Receives: Drug: Ritlecitinib

What is being measured

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

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib
AUCinf was defined as area under the plasma-concentration time profile from time zero extrapolated to infinite time. AUCinf for ritlecitinib was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.
Maximum Observed Concentration (Cmax) of Ritlecitinib
Cmax was defined as maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.

Secondary outcomes (2)

Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)
Number of Participants With Laboratory Abnormalities
Hematology included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy. Laboratory abnormalities were judged by the investigator. Laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
Measured: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)

Timeline

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

9 May 202324 Jul 2023

First posted10 May 2023
Study start9 May 2023
Primary completion15 Jun 2023
Study completion24 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 VolunteersStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05852340
Sponsor's protocol ID: B7981078
Other IDs: 2022-502872-22-00
Status last verified: Oct 2024
First submitted: 1 May 2023
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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 Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) SPRINKLED IN APPLESAUCE, YOGHURT AND STRAWBERRY JAM RELATIVE TO INTACT BLEND-IN CAPSULE OF RITLECITINIB AND THE EFFECT OF FOOD ON THE BIOAVAILABILITY OF THE INTACT BLEND-IN CAPSULE DOSAGE FORMULATION OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05852340
Acronym / sponsor ID: B7981078
Conditions: Healthy Volunteers, Adult, Pharmacokinetics
Keywords: Adult, Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 9 May 2023 (actual)
Primary completion: 15 Jun 2023 (actual)
Study completion: 24 Jul 2023 (actual)
First posted: 10 May 2023 (actual)
Results: Posted 16 Oct 2024

Clinical summary

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

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.

This study is seeking participants who are:

aged 18 or older;
male or female who are healthy as determined by medical assessment ;
Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

Detailed description

Tolerability and safety will be assessed for all treatments by monitoring AEs.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Treatment A	Active comparator	Drug: Ritlecitinibritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state
Treatment B	Active comparator	Drug: Ritlecitinibcontents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state
Treatment C	Active comparator	Drug: Ritlecitinibcontents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state
Treatment D	Active comparator	Drug: Ritlecitinibcontents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state
Treatment E	Active comparator	Drug: Ritlecitinibritlecitinib 1 x 30 mg intact BiC given with high fat meal

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 18 or older.
Male or female who are healthy as determined by medical assessment.
Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

Key exclusion criteria (3 listed)

Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency, or infections (acute or chronic).

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
RitlecitinibAlso: PF-06651600ritlecitinib 1 x 30 mg intact BiC (Treatment Arms A, E) ritlecitinib 1 x 30 mg intact BiC sprinkled on soft foods (Treatment Arms B, C, D)	Drug	Treatment A, Treatment B, Treatment C, Treatment D, Treatment E

Primary outcome

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.
AUCinf was defined as area under the plasma-concentration time profile from time zero extrapolated to infinite time. AUCinf for ritlecitinib was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Maximum Observed Concentration (Cmax) of Ritlecitinib
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.
Cmax was defined as maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data.

2 secondary outcomes

Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs)
Time frame: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)
Number of Participants With Laboratory Abnormalities
Time frame: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)

Results and safety

Results posted to the registry on 16 Oct 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
Sequence 1: Treatment A-> B-> C-> D-> E	3	3
Sequence 2: Treatment B-> D-> A-> C-> E	3	3
Sequence 3: Treatment C-> A-> D-> B-> E	3	3
Sequence 4: Treatment D-> C-> B-> A-> E	3	3

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Ritlecitinib 30 mg Capsule (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) n = 12	Ritlecitinib 30 mg Capsule Given With High Fat Meal n = 9
Value	389.1 (32)	398.3 (31)	378.0 (27)	387.8 (27)	387.0 (23)

Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted): Ratio (%) of Adjusted Geometric Means: 102.36 (90% CI 95.81 to 109.35)
Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted): Ratio (%) of Adjusted Geometric Means: 97.15 (90% CI 90.94 to 103.79)
Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted): Ratio (%) of Adjusted Geometric Means: 99.65 (90% CI 93.28 to 106.46)

Population analysed: All participants randomized and treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.

Primary outcome: Maximum Observed Concentration (Cmax) of Ritlecitinib

Measure	Ritlecitinib 30 mg Capsule (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) n = 12	Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) n = 12	Ritlecitinib 30 mg Capsule Given With High Fat Meal n = 10
Value	244.3 (35)	236.1 (28)	206.6 (24)	229.4 (25)	108.0 (28)

Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted): Ratio (%) of Adjusted Geometric Means: 96.63 (90% CI 83.66 to 111.62)
Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted): Ratio (%) of Adjusted Geometric Means: 84.58 (90% CI 73.23 to 97.70)
Ritlecitinib 30 mg Capsule (Fasted) vs Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted): Ratio (%) of Adjusted Geometric Means: 93.91 (90% CI 81.30 to 108.48)

Population analysed: All participants randomized and treated who had at least 1 of the PK parameters of primary interest.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ritlecitinib 30 mg Capsule (Fasted)	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Ritlecitinib 30 mg Capsule Given With High Fat Meal	0 of 10 (0%)	2 of 10 (20%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 Ritlecitinib in people with Healthy Volunteers and Adult, run by Pfizer at 1 site in Belgium.

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 3 inclusion and 3 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 16 Oct 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 Belgium. 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?

Yes. Results are posted in the registry (first posted 16 Oct 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?

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib (time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.). 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?

On the ClinicalTrials.gov record for NCT05852340.

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 16 Oct 2024; AzTrials last refreshed its copy on 3 Nov 2026.