DiarrheaPhase 1PISCESNCT01823939
PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera
A Phase 1 study testing iOWH032 in people with Diarrhea and Cholera, run by PATH at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- What is being tested?
- iOWH032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An individual will be considered eligible for participation in the trial if the following inclusion criteria are satisfied:
- 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.
- 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:
- Males aged 18 years to 55 years, inclusive;
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- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Participants unwilling or unable to take part in this study or refusing to sign informed consent;
- Participants previously enrolled in this or any other investigational study with the past 30 days.
- 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.
- A patient with any of the following criteria at screening for study enrolment will not qualify for the study:
- History of receiving antimicrobial or anti-diarrhoeal medication (loperamide, diphenoxylate, etc.) within the seven days of admission;
- Clinically significant abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate;
- Use of drugs metabolized predominantly via CYP2C93 within seven days of admission;
- Evidence or history of any clinically significant illness as per the Investigator's discretion
- Evidence or history of concomitant infection requiring antimicrobial therapy
- Known hypersensitivity to, or intolerance of iOWH032 or the excipients
- Past history of gastric, small intestinal, or colonic surgery, not including appendectomy or cholecystectomy
- Patients unwilling or unable to take part in this study or refusing to sign informed consent
- Patients previously enrolled in this or any other investigational study with the past 30 days.
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)
Mohakhali, Dhaka Division, 1212
About this study
Official title: Two-Part, Single-Centre Pharmacokinetic Study of iOWH032 in Adult Male and Female Healthy Volunteers, and Adult Males With Cholera
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.
Read the 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.
- Being tested
- iOWH032
- Keywords
- Cholera, V. Cholerae O1, iOWH032, diarrhoea, pharmacokinetic, Bangladesh
- Medical subject headings
- Diarrhea, Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iOWH032Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: iOWH032 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through end of treatment (Day 150)
Secondary outcomes (1)
Measure of Adverse Events
The safety and tolerability endpoint for this study is adverse events (AEs). All participants and patients receiving investigational product (iOWH032) will be included in the safety analysis. Laboratory values, physical examinations and vital signs will be summarized over time and treatment group using the descriptive statistics and plots.
Measured: 7 days after receipt of the single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed A Salam, MBBS, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823939
- Sponsor's protocol ID
- PK Study
- Other IDs
- DDP CFT PO 201
- Acronym
- PISCES
- Status last verified
- Jun 2015
- First submitted
- 27 Mar 2013
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part, Single-Centre Pharmacokinetic Study of iOWH032 in Adult Male and Female Healthy Volunteers, and Adult Males With Cholera
- ClinicalTrials.gov ID
- NCT01823939
- Acronym / sponsor ID
- PISCES / PK Study
- Keywords
- Cholera, V. Cholerae O1, iOWH032, diarrhoea, pharmacokinetic, Bangladesh
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males / Females (Healthy) | Other | Drug: iOWH032Part 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. |
| Males (Patient) | Other | Drug: iOWH032Part 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- An individual will be considered eligible for participation in the trial if the following inclusion criteria are satisfied:
- 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.
- 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:
Key exclusion criteria (30 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iOWH032Part 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. | Drug | Males (Patient), Males / Females (Healthy) |
Primary outcome
Calculation of concentration-time data
Time frame: Day 1 through end of treatment (Day 150)
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.
1 secondary outcome
Measure of Adverse Events
Time frame: 7 days after receipt of the single dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Salam, MBBS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iOWH032 in people with Diarrhea and Cholera, run by PATH at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of concentration-time data (time frame: Day 1 through end of treatment (Day 150)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.