Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects

NCT04729088 | Withdrawn Phase 1

• 1 other identifier: CAEP 56.003.19PC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects.

Conditions

Pharmacokinetics; Healthy Subjects

Keywords

Isosorbide Mononitrate; Pharmacokinetics; Intra anal application; Anal Fissure; Healthy volunteers

Outcome Measures

Primary Outcomes (6)

• Area under the plasma concentration versus time curve from time zero to last (AUC 0-last)

  36 hours

• Area under the plasma concentration versus time curve from time zero to infinite (AUC 0-inf)

  36 hours

• Maximum (peak) plasma concentration (Cmax)

  36 hours

• Time to reach maximum (peak) plasma concentration (Tmax)

  Time frame from drug administration to sampling time of maximum plasma concentration

  36 hours

• Elimination rate constant (Ke)

  36 hours

• Half life (t1/2)

  36 hours

Secondary Outcomes (3)

• Number of adverse events

  15 days

• Blood Pressure

  1 day

• Pulse

  1 day

Study Arms (1)

Test Drug

EXPERIMENTAL

Isosorbide 0.5% gel

Drug: Isosorbide mononitrate

Interventions

Isosorbide mononitrate DRUG

Intra-anal application performed by the study physician of 2 g of the study drug

Test Drug

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged from 18 to 50 years-old;
• Good health conditions or without significant diseases, according to medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory test;
• Ability to understand the nature and objectives of the trial, including risks and adverse events;
• Willingness to proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature;
• Agree to use safe contraceptive method.

You may not qualify if:

• Known to have hypersensitivity reaction to the studied drug or to chemically related compounds;
• History or presence of chronic gastrointestinal diseases or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
• Maintenance therapy with any drug known to interact with the investigational drug, except contraceptives;
• History of liver, kidney, lung, gastrointestinal, epileptic, haematological or psychiatric disease; hypertension of any etiology; history of myocardial infarction, angina and / or heart failure or malignant neoplasms. Have any current disease, acute or chronic, in follow-up or treatment;
• Have active orificial pathology, such as hemorrhoidal thrombosis, acute or chronic anal fissures, as assessed by the study physician within 15 days from confinement;
• Electrocardiographic findings not recommended at the physician's discretion to participate in the study;
• History of cardiac (any), renal (renal exeresis or agenesis), gastrointestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid or rectum), liver or pancreas surgery;
• Screening laboratory test results outside normal ranges set by the clinical analysis laboratory, unless considered non-clinically significant by the Principal Investigator / Physician;
• Smoker (more than five cigarettes / day);
• Eating foods containing xanthine, including more than five cups of coffee or tea per day;
• Unusual eating habits, eg vegetarians;
• History of excessive alcohol consumption (drinking 4 or more alcoholic beverages in one day or 8 or more alcoholic beverages per week for women and 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week for men);
• History of drug use;
• Use of regular medication within two weeks prior to initiation of treatment and the date of pre-confinement clinical assessment;
• Use of medication containing sildenafil, vardenafil or riociguate, up to 03 days before confinement;

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

MeSH Terms

Conditions

Fissure in Ano

Interventions

isosorbide-5-mononitrate

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• José Pedrazzoli Jr., MD

  CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Phase I, single-center, single-dose clinical trial (test drug), in which participants will receive the test drug intra-anal

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: December 20, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01