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Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1% (ATOFEX-1)

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Rash

Status

Completed

Phase

Phase 1

Locations

Bangladesh

Study Type

Interventional

Intervention

Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Inflammatory Skin Disease, Pruritus, Rash, Atopic Dermatitis, Urticaria, Psoriasis, Eczema

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male human subjects between 18 to 45 years of age (both inclusive).
Having a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 (both inclusive).
Have no abnormal findings during screening done 21 days prior to administration of study drug, medical history and examination, laboratory evaluations, 12-lead ECG recordings.
Has an optimum physical condition which enables subjects to be fit for a Pharmacokinetic sampling according to principal investigator's evaluation.
Able to comply with the study procedures in the opinion of the PI/CI.
Able to give written consent for participation in the study.
Subjects who have taken at least two doses of COVID 19 vaccine and possess certificate for the same.
Intact skin without major scarring or tattoos.
An unusual diet (e.g., low salt), for any medical reason or non-medical reason for three weeks prior to receiving the study drug and throughout the subjects' participation in the study. In any such case subject selection will be at the discretion of the PI/CI.

Exclusion Criteria:

Known hypersensitivity or idiosyncratic reaction to Fexofenadine Hydrochloride or any of the excipients in the formulation.
Diagnosed with, or a family history of, long QT syndrome (LQTS).
Skin disorders or current skin discomforts.
Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system.
Ingestion of any medicine at any time within 14 days before Check In. In any such case subject selection will be at the discretion of the PI/CI and medicine taken will be recorded.
Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticaria.
History of substance abuse and or addiction to drugs and alcohol.
Smokers, who smoke 9 or more cigarettes / day or inability to abstain during the study.
Habituated to drinking tea or coffee (more than 5 cups/day) or inability to abstain during the study
Habituated to tobacco/tobacco containing products (more than 10 gm/day) or inability to abstain during the study.
A positive result for Serological tests [including hepatitis B & C, HIV antibody and syphilis {VDRL (RPR) /TPHA}] tests.
Donation of blood (1 unit: 350 mL) within 90 days prior to receiving the first dose of study drug.
The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.

Sites / Locations

BCT Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OP2101

Arm Description

Treatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Outcomes

Primary Outcome Measures

Adverse Events

Incidence and severity of local and systemic Adverse Events (AEs).

Cmax

Peak plasma concentration (Cmax)

Tmax

Peak plasma time (Tmax)

T½

Half-life (T½)

AUC0-72h

Area under the curve (AUC0-72h)

Secondary Outcome Measures

Dermal tolerability and treatment perception

Skin- and Lotion Assessment Questionnaire (SLAQ) is a proprietary 3-part questionnaire: Part 1 is a 6-modalities, 4-grade self-assessment of skin perceptions. Part 2 is the Local Tolerability Scale (LTS). Part 3 is a 7-modalities, 5-grade assessment of cream properties.

Full Information

NCT ID

NCT05461456

First Posted

July 2, 2022

Last Updated

March 27, 2023

Sponsor

OrchestratePharma GmbH

Collaborators

VidiLife Clinical Research Associate

1. Study Identification

Unique Protocol Identification Number

NCT05461456

Brief Title

Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

Acronym

ATOFEX-1

Official Title

An Open Label, Single-Dose, Single-Treatment, Single-Period Safety and Bioavailability Study of Fexofenadine Hydrochloride Topical Lotion 1% in Healthy, Adult, Male Human Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

October 16, 2022 (Actual)

Study Completion Date

October 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OrchestratePharma GmbH

Collaborators

VidiLife Clinical Research Associate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The investigational lotion is envisaged as an short- and long term "Ease & Prevent" monotherapy for adults and children with mild to moderate eczema. With itch representing the most burdensome symptom in eczema, the main objectives with the lotion is fast and efficient itch relief, high tolerability, and high short- and long term safety. This phase 1 study aims to monitor skin tolerability, and how much of the active compound that is absorbed to the bloodstream.

Detailed Description

Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) is a novel formulation developed for the treatment of skin disorders characterized by pruritus. Research show that oral Fexofenadine Hydrochloride (FX) may lead to a small improvement of pruritus in patients with Atopic Dermatitis (AD). In clinical practice, oral antihistamines are widely used off-label for pruritus relief in AD, indicating a discrepancy in trial outcomes and real-life experience. The pre-study thesis postulates that the antipruritic effect of FX can be leveraged in a dose-response relationship facilitated by high topical concentration of FX in direct contact with the pathological process of the skin. The sponsor also suggest that the Cytosolic phospholipase A2 (cPLA2) blocking property of FX is an untapped resource that is likely to be dose-response dependent and manifested by means of high topical concentration in proximity to the inflammatory process. The repositioning of FX to a topical treatment has the potential for high safety, efficacy, fast relief, and ease of use. OP2101 is also aimed at inflammation control, suppression of bacterial imbalance, moisture retention, upregulation of antimicrobial peptides, and skin barrier restoration. As such, it targets six of the pathological pillars of AD. Assessment of topical tolerability and skin adsorption (systemic exposure) are the main objectives in this phase 1 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Rash, Rash, Pruritus, Urticaria, Urticaria Chronic, Psoriasis, Psoriasis Vulgaris, Skin Rash, Skin Inflammation, Eczema

Keywords

Inflammatory Skin Disease, Pruritus, Rash, Atopic Dermatitis, Urticaria, Psoriasis, Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

The study is an 'Open Label, Single-Dose, Single-Treatment, Single-Period Safety and Bioavailability Study in Healthy, Adult, Male Human Subjects, where the subjects will be housed in the clinical facility from not less than 11 hours pre-dose till at least 72 hours post-dose. Altogether, the subject will stay for consecutive 03 days and 04 nights in the facility.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OP2101

Arm Type

Experimental

Arm Description

Treatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Intervention Type

Drug

Intervention Name(s)

Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Intervention Description

Intervention: The amount of study lotion (OP2101) used is 11 grams per subject, equivalent to 22 fingertip units (FTU). The lotion is applied to the subject on back and front of the trunk, both hands (palm and back) and both arms. An SOP for handling and application of the lotion ensures the 11 grams covers 54% of the body surface area (BSA) evenly without residue. Comment: The treatment is single-dose and single-treatment. The FTU is used to standardize the amount of cream being applied in clinical research. It is also used in clinical practice and hence connects the objectiveness of the trial to the clinical situation.

Primary Outcome Measure Information:

Title

Adverse Events

Description

Incidence and severity of local and systemic Adverse Events (AEs).

Time Frame

0-72 hours

Title

Cmax

Description

Peak plasma concentration (Cmax)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Title

Tmax

Description

Peak plasma time (Tmax)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Title

T½

Description

Half-life (T½)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Title

AUC0-72h

Description

Area under the curve (AUC0-72h)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Secondary Outcome Measure Information:

Title

Dermal tolerability and treatment perception

Description

Time Frame

-60 minutes, 30 minutes, 72 hours

Other Pre-specified Outcome Measures:

Title

Radial pulse

Description

Radial pulse (beats per minute)

Time Frame

At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.

Title

Systolic blood pressure

Description

Systolic blood pressure (mmHg)

Time Frame

At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.

Title

Diastolic blood pressure

Description

Diastolic blood pressure (mmHg)

Time Frame

At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.

Title

Respiratory rate

Description

Respiratory rate (breaths per minute)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Title

Body temperature

Description

Body temperature (Celsius degrees)

Time Frame

0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male human subjects between 18 to 45 years of age (both inclusive). Having a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 (both inclusive). Have no abnormal findings during screening done 21 days prior to administration of study drug, medical history and examination, laboratory evaluations, 12-lead ECG recordings. Has an optimum physical condition which enables subjects to be fit for a Pharmacokinetic sampling according to principal investigator's evaluation. Able to comply with the study procedures in the opinion of the PI/CI. Able to give written consent for participation in the study. Subjects who have taken at least two doses of COVID 19 vaccine and possess certificate for the same. Intact skin without major scarring or tattoos. An unusual diet (e.g., low salt), for any medical reason or non-medical reason for three weeks prior to receiving the study drug and throughout the subjects' participation in the study. In any such case subject selection will be at the discretion of the PI/CI. Exclusion Criteria: Known hypersensitivity or idiosyncratic reaction to Fexofenadine Hydrochloride or any of the excipients in the formulation. Diagnosed with, or a family history of, long QT syndrome (LQTS). Skin disorders or current skin discomforts. Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system. Ingestion of any medicine at any time within 14 days before Check In. In any such case subject selection will be at the discretion of the PI/CI and medicine taken will be recorded. Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticaria. History of substance abuse and or addiction to drugs and alcohol. Smokers, who smoke 9 or more cigarettes / day or inability to abstain during the study. Habituated to drinking tea or coffee (more than 5 cups/day) or inability to abstain during the study Habituated to tobacco/tobacco containing products (more than 10 gm/day) or inability to abstain during the study. A positive result for Serological tests [including hepatitis B & C, HIV antibody and syphilis {VDRL (RPR) /TPHA}] tests. Donation of blood (1 unit: 350 mL) within 90 days prior to receiving the first dose of study drug. The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.

Facility Information:

Facility Name

BCT Ltd.

City

Dhaka

State/Province

Ramna

ZIP/Postal Code

1217

Country

Bangladesh

12. IPD Sharing Statement

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Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

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