Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

NCT05461456 | Completed Phase 1

• 1 other identifier: iVRS-CD-22-021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Adverse Events

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

  0-72 hours

• Cmax

  Peak plasma concentration (Cmax)

  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.

• Tmax

  Peak plasma time (Tmax)

  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.

• T½

  Half-life (T½)

  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.

• AUC0-72h

  Area under the curve (AUC0-72h)

  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 Outcomes (1)

• Dermal tolerability and treatment perception

  -60 minutes, 30 minutes, 72 hours

Other Outcomes (5)

• Radial pulse

  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.

• Systolic blood pressure

  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.

• Diastolic blood pressure

  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.

Study Arms (1)

OP2101

EXPERIMENTAL

Treatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Drug: Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Interventions

Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) DRUG

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.

OP2101

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrchestratePharma GmbH: lead
• VidiLife Clinical Research Associate: collaborator

Study Sites (1)

BCT Ltd.

Dhaka, Ramna, 1217, Bangladesh

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Exanthema; Pruritus; Urticaria; Chronic Urticaria; Psoriasis; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Vascular; Chronic Disease; Disease Attributes; Pathologic Processes; Skin Diseases, Papulosquamous

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 18, 2022
• Study Start: April 1, 2022
• Primary Completion: October 16, 2022
• Study Completion: October 16, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

BA (1)