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Intra-anal Oxymetazoline in Healthy Adult Volunteers | Clinical Trials | Clareo Health

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Intra-anal Oxymetazoline in Healthy Adult Volunteers

A Phase I, Open-Label, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intra-anal Application of Topical Oxymetazoline Gel in Healthy Adult Volunteers

NCT03529487•RDD Pharma Ltd

View on ClinicalTrials.gov

Summary

This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. A total of 32 healthy male and female subjects will be enrolled to receive either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C, n=8) applied intra-anally daily (QD) for 11 consecutive days.

Detailed Description

This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. The primary objective of this study is to determine the plasma concentrations and PK parameters, as data allows, of oxymetazoline following single and repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects. The secondary objective of this study is to evaluate the safety and tolerability of repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects. A total of 32 healthy male and female subjects will be enrolled (16 subjects in the first cohort and 8 subjects in the remaining cohorts) and will be exposed to Topical Oxymetazoline 1 mg, 5 mg or 10 mg applied intra-anally QD for 11 consecutive days.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
•2. Subject is an adult male or female between the ages of 18 and 60 years, inclusive.
•3. Female subjects of child-bearing potential must have a negative urine pregnancy test. Females of childbearing potential must practice a highly effective method of pregnancy prevention (defined as \<1% pregnancies per 100 women per year) from one month before screening to one month after the follow-up visit, such as: surgical sterilization, hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal spermicide. Female subject with any of the following circumstances is not required to use a highly effective method of pregnancy prevention: status post-hysterectomy; or, status post-tubal ligation; or, post-menopausal state (defined as \>= 12 months of spontaneous amenorrhea) or \< 12 months of spontaneous amenorrhea with a blood follicle stimulating hormone \> 40 MIU/ml.
•4. Subject has a body mass index between 18 and 33 kg/m2 (weight/\[height\]2).
•5. Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening.
•6. Subject is healthy based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and have no more than 3 spontaneous bowel movements (SBM) a day or no less than 3 SBMs a week.
•7. Based on single or averaged QTc values of triplicate ECGs over a brief recording period, QTc \< 450 msec
•8. Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures, including retaining a rectal gel for at least 60 min and undergoing repeat rectal manometries lasting 10-15 min.
•9. Subject has not consumed and agrees to abstain from taking any prescription or non-prescription medications, including herbal and dietary supplements (such as St. John's wort) within 14 days prior to the first dose of study medication (except as authorized by the Investigator and Medical Monitor).
•10. Subject has not consumed alcohol-containing beverages for 3 days prior to the first scheduled dose and agrees not to consume alcohol through the last study visit.
+1 more criteria

Exclusion Criteria

•1. Subject has a hypersensitivity or allergy to oxymetazoline.
•2. Subject has active or history of cardiovascular or cerebrovascular disease including hypertension, unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities.
•3. Subject has systolic blood pressure \>130 mm Hg and/or diastolic blood pressure \>80 mm Hg and/or resting heart rate \>90 bpm or resting heart rate \<50 bpm.
•4. Subject has glaucoma (narrow-angle), Raynaud's disease/phenomenon, thromboangiitis obliterans, scleroderma, and/or Sjögren's syndrome.
•5. Subject has diabetes per medical history or has fasting plasma glucose level \> 7 mmol/l (126 mg/dl) at screening or has Glycated hemoglobin (HbA1C) ≥ 48 mmol/mol (≥ 6.5 DCCT %) at screening.
•6. Subject has thyroid problems such as medical history of hypothyroidism, hyperthyroidism, sick euthyroid syndrome, thyroid cancer, thyroid surgery, Radioiodine treatment or enlarged thyroid upon physical examination, or thyroid nodule upon physical examination, or abnormal thyroid-stimulating hormone (TSH) at screening defined as level \>4.0 mIU/mL or level \<0.4 mIU/mL.
•7. Subject with enlarged prostate as per medical history or per rectal examination in screening.
•8. Subject has a history of rectal surgery.
•9. Subject has upon physical examination a rectal deformation or signs of rectal disease such as fissure, hemorrhoids grade 3, rectal prolapse, fistula, infection or space occupying lesion.
•10. Subjects with a history of or present symptoms related to irritable bowel disease, inflammatory bowel disease, or chronic constipation.
+19 more criteria

Locations (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, United States

Key Dates

Start Date

August 20, 2018

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

August 2, 2022

Enrollment

ESTIMATED participants

Conditions

Fecal Incontinence

Interventions

Oxymetazoline

DRUG

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Fecal Incontinence

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intra-anal Oxymetazoline in Healthy Adult Volunteers

Inclusion Criteria

Exclusion Criteria

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