Healthy ParticipantsPhase 1NCT01994083
A Study of Multiple Oral Doses of IX-01 in Healthy Men
A Phase 1 study testing IX-01 in people with Healthy Participants, run by Ixchelsis Limited at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- IX-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Mar 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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))
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- Placebo, IX-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered orally
IX-01Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| IX-01 | Experimental | Up to 4 different dose groups within 50 to 1,200 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days Receives: Drug: IX-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: Baseline to Day 20 (Estimated up to 3 weeks)
Secondary outcomes (13)
Peak Plasma Concentration (Cmax) of IX-01
Measured: Pre-dose to 24 hours post dose on Days 1 and 10
Area Under the Plasma Concentration-Time Curve (AUCtau)
Measured: Pre-dose up to 24 hours post dose on Days 1 and 10
Time of Peak Plasma Concentration (Tmax) of IX-01
Measured: Pre-dose to 24 hours post dose on Days 1 and 10
Elimination Half Life (t1/2) of IX-01
Measured: Pre-dose up to 96 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on AUCtau
Measured: Pre-dose up to 24 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on Cmax
Measured: 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
Measured: Pre-dose to 96 hours post dose on Day 10
Minimum Observed Concentration (Ctrough) of IX-01
Measured: Pre-dose on Days 2 to 10
Elimination Rate Constant (Kel) of IX-01
Measured: Pre-dose up to 96 hours post dose on Day 10
Apparent Clearance of IX-01
Measured: Pre-dose up to 24 hours post dose on Day 10
Apparent Volume of Distribution During the Terminal Phase of IX-01
Measured: Pre-dose up to 96 hours post dose on Day 10
Urine 6-β-hydroxycortisol/cortisol Ratio
Measured: Pre-dose on Day 1 and Day 10
IX-01 Concentration and Amount Secreted in Semen
Measured: Between 2 and 4 hours after dosing, on Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ixchelsis Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email: Ixchelsis@Choruspharma.com, Study director, Ixchelsis Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994083
- Sponsor's protocol ID
- IX-0101
- Status last verified
- Sep 2014
- First submitted
- 19 Nov 2013
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01994083
- Acronym / sponsor ID
- IX-0101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ixchelsis LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| IX-01 | Experimental | Drug: IX-01Up to 4 different dose groups within 50 to 1,200 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| PlaceboAdministered orally | Drug | Placebo |
| IX-01Administered orally | Drug | IX-01 |
Primary outcome
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)
13 secondary outcomes
Peak Plasma Concentration (Cmax) of IX-01
Time frame: 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
Time of Peak Plasma Concentration (Tmax) of IX-01
Time frame: 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
Accumulation Ratio (Racc) of IX-01 based on AUCtau
Time frame: 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
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
Minimum Observed Concentration (Ctrough) of IX-01
Time frame: 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
Apparent Clearance of IX-01
Time frame: 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
Urine 6-β-hydroxycortisol/cortisol Ratio
Time frame: 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
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 3 Sep 2014.
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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.
Email: Ixchelsis@Choruspharma.com study director
Ixchelsis Limited
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 IX-01 in people with Healthy Participants, run by Ixchelsis Limited at 1 site in United Kingdom.
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 6 inclusion and 16 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 3 Sep 2014. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
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)). 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 3 Sep 2014.