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

NCT01823939 | Completed Phase 1 DMC

• 2 other identifiers: PK StudyDDP CFT PO 201
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Cholera

Keywords

Cholera; V. Cholerae O1; iOWH032; diarrhoea; pharmacokinetic; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Calculation of concentration-time data

  For both Part A and Part B: * pharmacokinetic parameters * adverse events (AEs) * laboratory values * physical examination and vital sign findings * summary statistics For Part B, patients with culture-proven V. cholerae O1 infection will be evaluated independently of those with a negative culture. Those who are culture negative for V. cholerae but have received iOWH032 will remain in the study and the same protocol will be followed for their management including the follow up visit.

  Day 1 through end of treatment (Day 150)

Secondary Outcomes (1)

• Measure of Adverse Events

  7 days after receipt of the single dose

Study Arms (2)

Males / Females (Healthy)

OTHER

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.

Drug: iOWH032

Males (Patient)

OTHER

Part B: Patients will be eligible for the study if they have clinically severe dehydration and meet all other inclusion and exclusion criteria. Upon signing consent, they will be admitted to the Research Ward of the Dhaka Hospital of icddr,b.

Drug: iOWH032

Interventions

iOWH032 DRUG

Part A: Participants will be randomized at a 3:1 ratio to receive treatment with iOWH032 or placebo. A randomisation code will be generated. Each participant will be assigned the next participant number available and thereby will be assigned randomly. Active treatment will consist of an oral tablet containing 300 mg of iOWH032. The placebo will consist of identical looking tablets. Part B: There will be no randomization during this trial. All eligible patients will receive 300 mg of iOWH032.

Males (Patient); Males / Females (Healthy)

Eligibility Criteria

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

You may qualify if:

• Male or female between 18 and 55 years, inclusive;
• 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.
• Written informed consent for participation in the study.
• Males aged 18 years to 55 years, inclusive;
• Duration of illness: History of acute watery diarrhoea of less than 24 hours duration without fever or visible blood in faeces;
• Clinical signs and symptoms of severe dehydration;
• A stool Dark-field microscopy or Rapid Strip test demonstrating presence of V. cholerae.
• Written informed consent for participation in the study.

You may not qualify if:

• An individual with any of the following criteria at screening for study enrolment will not qualify for the study:
• 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;
• History of cancer with the exception of basal cell or squamous cell (skin) carcinoma;
• History of drug or alcohol abuse or dependence (based on DSM-IV criteria) within the past two years;
• 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;
• Sustained systolic blood pressure \> 140 mmHg or \< 95 mmHg or a diastolic blood pressure \> 95 mmHg obtained in the seated position;
• Heart rate at rest of \< 40 bpm or \> 100 bpm;
• Clinically significant abnormal ECG findings, as determined by the investigator;
• Clinically significant abnormal laboratory test results, as determined by the investigator;
• 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;
• Evidence or history of any clinically significant illness as per the Investigator's discretion
• Past history of gastric, small intestinal, or colonic surgery, not including appendectomy or cholecystectomy;
• Positive HBsAg or anti-HCV Ab;
• Positive urine test for drug(s) of abuse: benzodiazepines, cocaine, marijuana, methamphetamine, and opiates;
• Known hypersensitivity to, or intolerance of the excipients in the study medication;

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)

Mohakhali, Dhaka Division, 1212, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Cholera

Interventions

IOWH-032

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mohammed A Salam, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 4, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

BA (1)