PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera

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Brief Title

PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera

Official Title

Two-Part, Single-Centre Pharmacokinetic Study of iOWH032 in Adult Male and Female Healthy Volunteers, and Adult Males With Cholera

Brief Summary

      This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are
      grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients.
      This is not a hypothesis-driven research study.
    

Detailed Description

      This study will be conducted in two parts.

      The first part (Part A) will evaluate the pharmacokinetics, safety and tolerability of
      iOWH032 in healthy, adult Bangladeshi volunteers.

      The second part (Part B) will evaluate the pharmacokinetics, safety and tolerability of
      iOWH032 in adult Bangladeshi patients with cholera. While female participants will be
      included in Part A, only male patients will be enrolled in Part B. The rationale for
      excluding women in Part B is the difficulty in separating urine from stool in severely
      dehydrated females with rapid rates of purging. Moreover, it has been difficult to retain
      adult females in the hospital after improvement of their diarrhoea because of their household
      responsibilities, which might impact compliance in this small study. Further, no sex
      differences in the pharmacokinetics of iOWH032 were found in the study conducted in healthy
      subjects in the US, which included 42 males and females, nor have sex differnces been
      observed in preclinical studies.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Calculation of concentration-time data

Secondary Outcome

 Measure of Adverse Events

Condition

Diarrhea

Intervention

iOWH032

Study Arms / Comparison Groups

 Males / Females (Healthy)
Description:  Part A: This initial part of the study will be conducted in adult Bangladeshi healthy volunteers (4 males, 4 females) to assess the pharmacokinetics, safety, and tolerability of single doses of iOWH032. Participants will be admitted to the Clinical Trial Unit (CTU) of icddr,b (located at a 10 minute drive from the icddr,b main campus) the day prior to dosing and remain for 48 hours after dosing, unless treatment and/or follow-up of an adverse event (AE) require longer in-unit observation or treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

26

Start Date

May 2013

Completion Date

December 2014

Primary Completion Date

November 2013

Eligibility Criteria

        INCLUSION CRITERIA - Part A:

        An individual will be considered eligible for participation in the trial if the following
        inclusion criteria are satisfied:

          1. Male or female between 18 and 55 years, inclusive;

          2. Female participants are non-pregnant and non-lactating. Female participants of
             childbearing potential (including perimenopausal women who had menstrual bleeding
             within the past two years) must use appropriate birth control (abstinence and/or
             double barrier methods) for 30 days after dosing. Acceptable double barrier methods
             are the following forms of contraception: condom, contraceptive sponge, hormonal
             contraceptives, intrauterine devices, and diaphragm or cervical ring with spermicidal
             gel or foam. Women are considered to be not of childbearing potential if they have
             been surgically sterilized (physician-documented hysterectomy, bilateral oophorectomy
             or bilateral tubal ligation). All female participants must have a negative pregnancy
             test at screening and on admission to the CTU.

          3. Written informed consent for participation in the study.

        INCLUSION CRITERIA - Part B:

        A patient will be considered eligible for participation in the trial if the following
        inclusion criteria are satisfied on admission (Day 1) to the hospital:

          1. Males aged 18 years to 55 years, inclusive;

          2. Duration of illness: History of acute watery diarrhoea of less than 24 hours duration
             without fever or visible blood in faeces;

          3. Clinical signs and symptoms of severe dehydration;

          4. A stool Dark-field microscopy or Rapid Strip test demonstrating presence of V.
             cholerae.

          5. Written informed consent for participation in the study.

        EXCLUSION CRITERIA - Part A:

        An individual with any of the following criteria at screening for study enrolment will not
        qualify for the study:

          1. Evidence or history of clinically significant allergic, haematological, immunological,
             endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or
             neurological disease; or any other condition likely to interfere with the absorption,
             disposition, metabolism, or excretion of the investigational product;

          2. History of cancer with the exception of basal cell or squamous cell (skin) carcinoma;

          3. History of drug or alcohol abuse or dependence (based on DSM-IV criteria) within the
             past two years;

          4. Donated blood or plasma, or experienced significant loss of blood within eight weeks
             prior to admission to the CTU or who plan to donate blood or plasma within one month
             after study participation;

          5. Sustained systolic blood pressure > 140 mmHg or < 95 mmHg or a diastolic blood
             pressure > 95 mmHg obtained in the seated position;

          6. Heart rate at rest of < 40 bpm or > 100 bpm;

          7. Clinically significant abnormal ECG findings, as determined by the investigator;

          8. Clinically significant abnormal laboratory test results, as determined by the
             investigator;

          9. Currently uses or has used tobacco or nicotine-containing products (e.g., cigarettes,
             cigars, chewing tobacco, snuff, etc.) within 30 days prior to admission to the CTU;

         10. Evidence or history of any clinically significant illness as per the Investigator's
             discretion

         11. Past history of gastric, small intestinal, or colonic surgery, not including
             appendectomy or cholecystectomy;

         12. Positive HBsAg or anti-HCV Ab;

         13. Positive urine test for drug(s) of abuse: benzodiazepines, cocaine, marijuana,
             methamphetamine, and opiates;

         14. Known hypersensitivity to, or intolerance of the excipients in the study medication;

         15. Taken over-the-counter (OTC) or prescription medications or herbal supplements (other
             than hormonal contraceptives, acetaminophen and/or multivitamins [acetaminophen
             2gm/day and multivitamins allowed up to 48 hours prior to dosing]) within 14 days;

         16. Participants unwilling or unable to take part in this study or refusing to sign
             informed consent;

         17. Participants previously enrolled in this or any other investigational study with the
             past 30 days.

         18. Any current or past condition or laboratory abnormality, which, in the opinion of the
             investigator, could confound or interfere with evaluation of safety, tolerability,
             and/or pharmacokinetics of the investigational drug, or prevent compliance with the
             study protocol.

        EXCLUSION CRITERIA - Part B:

        A patient with any of the following criteria at screening for study enrolment will not
        qualify for the study:

          1. History of receiving antimicrobial or anti-diarrhoeal medication (loperamide,
             diphenoxylate, etc.) within the seven days of admission;

          2. Clinically significant abnormal ECG findings, with the exception of sinus tachycardia,
             premature atrial contractions, or ECG intervals within normal limits for sinus rate;

          3. Use of drugs metabolized predominantly via CYP2C93 within seven days of admission;

          4. Evidence or history of any clinically significant illness as per the Investigator's
             discretion

          5. Evidence or history of concomitant infection requiring antimicrobial therapy

          6. Known hypersensitivity to, or intolerance of iOWH032 or the excipients

          7. Past history of gastric, small intestinal, or colonic surgery, not including
             appendectomy or cholecystectomy

          8. Patients unwilling or unable to take part in this study or refusing to sign informed
             consent

          9. Patients previously enrolled in this or any other investigational study with the past
             30 days.

         10. Any current or past condition or laboratory abnormality, which, in the opinion of the
             investigator, could confound or interfere with evaluation of safety, tolerability,
             and/or pharmacokinetics of the investigational drug, or prevent compliance with the
             study protocol.
      

Gender

All

Ages

18 Years - 64 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mohammed A Salam, MBBS, , 

Location Countries

Bangladesh

Location Countries

Bangladesh

Administrative Informations


NCT ID

NCT01823939

Organization ID

PK Study

Secondary IDs

DDP CFT PO 201

Responsible Party

Sponsor

Study Sponsor

PATH


Study Sponsor

Mohammed A Salam, MBBS, Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh


Verification Date

June 2015