A Study of Multiple Oral Doses of IX-01 in Healthy Men

September 2, 2014 updated by: Ixchelsis Limited

A Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of IX-01 in Healthy Male Subjects

The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine how the body handles IX-01.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Hammersmith Medicines Research (HMR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A body mass index (Quetelet index) in the range 18-30
  • Total body weight greater than (>)50 kilograms (kg) at screening
  • Able to understand the nature of the trial and any hazards of participating in it
  • Able to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
  • Participants and their partners must be willing to use adequate forms of contraception and comply with contraception requirements during the trial, and for 4 months after the last dose of medication
  • Must not plan to donate sperm or father a child during the trial, and for 4 months after the final dose of medication

Exclusion Criteria:

  • Clinically relevant abnormal history, physical findings, electrocardiogram (ECG), or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the participant
  • Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial or make it unnecessarily hazardous
  • Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, haematological, renal or neurological function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
  • Surgery (for example (e.g.) stomach bypass) or medical condition that might affect absorption, metabolism or elimination of medicines
  • Presence or history of severe adverse reaction to any drug
  • Use of any prescription or over-the-counter medicine during the 14 days before the first dose of trial medication, or intention to use any medicine during the trial, with the exception of short courses of medication considered by the investigator not to interfere with the safety of the participant or the integrity of the trial data (such as acetaminophen (paracetamol))
  • Current use of any herbal remedy or nutritional supplement, or intention to use any such product during the study
  • Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months
  • Previous participation in this trial or any other clinical trial of an oxytocin receptor antagonist
  • Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily
  • Blood pressure and heart rate in supine position at the screening examination outside the ranges 90-130 millimeters of mercury (mm Hg) systolic, 50-90 mm Hg diastolic; heart rate 50-90 beats/minute
  • Possibility that the participant will not cooperate with the requirements of the protocol
  • Evidence of drug abuse on urine testing
  • Positive test for hepatitis B, hepatitis C, Human Immunodeficiency Virus 1(HIV1) or Human Immunodeficiency Virus 2 (HIV2)
  • Loss of more than 400 milliliters (mL) blood during the 3 months before the trial, e.g. as a blood donor
  • Objection by General Practitioner (GP), on medical grounds, to participant entering trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Administered orally
Experimental: IX-01
Up to 4 different dose groups within 50 to 1,200 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days
Drug: IX-01
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Time Frame: Baseline to Day 20 (Estimated up to 3 weeks)
Baseline to Day 20 (Estimated up to 3 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax) of IX-01
Time Frame: Pre-dose to 24 hours post dose on Days 1 and 10
Pre-dose to 24 hours post dose on Days 1 and 10
Area Under the Plasma Concentration-Time Curve (AUCtau)
Time Frame: Pre-dose up to 24 hours post dose on Days 1 and 10
Pre-dose up to 24 hours post dose on Days 1 and 10
Time of Peak Plasma Concentration (Tmax) of IX-01
Time Frame: Pre-dose to 24 hours post dose on Days 1 and 10
Pre-dose to 24 hours post dose on Days 1 and 10
Elimination Half Life (t1/2) of IX-01
Time Frame: Pre-dose up to 96 hours post dose on Day 10
Pre-dose up to 96 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on AUCtau
Time Frame: Pre-dose up to 24 hours post dose on Day 10
Pre-dose up to 24 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on Cmax
Time Frame: Pre-dose up to 24 hours post dose on Days 1 and 10
Pre-dose up to 24 hours post dose on Days 1 and 10
Area Under the Concentration-Time Curve (AUCt) from Zero to the Time of Last Quantifiable Concentration (AUC(0-t)) of IX-01
Time Frame: Pre-dose to 96 hours post dose on Day 10
Pre-dose to 96 hours post dose on Day 10
Minimum Observed Concentration (Ctrough) of IX-01
Time Frame: Pre-dose on Days 2 to 10
Pre-dose on Days 2 to 10
Elimination Rate Constant (Kel) of IX-01
Time Frame: Pre-dose up to 96 hours post dose on Day 10
Pre-dose up to 96 hours post dose on Day 10
Apparent Clearance of IX-01
Time Frame: Pre-dose up to 24 hours post dose on Day 10
Pre-dose up to 24 hours post dose on Day 10
Apparent Volume of Distribution During the Terminal Phase of IX-01
Time Frame: Pre-dose up to 96 hours post dose on Day 10
Pre-dose up to 96 hours post dose on Day 10
Urine 6-β-hydroxycortisol/cortisol Ratio
Time Frame: Pre-dose on Day 1 and Day 10
Pre-dose on Day 1 and Day 10
IX-01 Concentration and Amount Secreted in Semen
Time Frame: Between 2 and 4 hours after dosing, on Day 9
Between 2 and 4 hours after dosing, on Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ixchelsis Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Email: Ixchelsis@Choruspharma.com, Ixchelsis Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IX-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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