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CompletedNCT01994083Updated Sep 3, 2014

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

A Phase 1 interventional study of Placebo and IX-01 in Healthy Participants, sponsored by Ixchelsis Limited. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-03.

Sponsored by Ixchelsis Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Ixchelsis Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A (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 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

Exclusion Criteria:

  • abnormal history, physical findings, (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 , , 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • 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

Interventions

  • DrugPlacebo

    Administered orally

  • DrugIX-01

    Administered orally

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of IX-01

    Time frame: Pre-dose to 24 hours post dose on Days 1 and 10

  2. Area Under the Plasma Concentration-Time Curve (AUCtau)

    Time frame: Pre-dose up to 24 hours post dose on Days 1 and 10

  3. Time of Peak Plasma Concentration (Tmax) of IX-01

    Time frame: Pre-dose to 24 hours post dose on Days 1 and 10

  4. Elimination Half Life (t1/2) of IX-01

    Time frame: Pre-dose up to 96 hours post dose on Day 10

  5. Accumulation Ratio (Racc) of IX-01 based on AUCtau

    Time frame: Pre-dose up to 24 hours post dose on Day 10

  6. Accumulation Ratio (Racc) of IX-01 based on Cmax

    Time frame: Pre-dose up to 24 hours post dose on Days 1 and 10

  7. 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

  8. Minimum Observed Concentration (Ctrough) of IX-01

    Time frame: Pre-dose on Days 2 to 10

  9. Elimination Rate Constant (Kel) of IX-01

    Time frame: Pre-dose up to 96 hours post dose on Day 10

  10. Apparent Clearance of IX-01

    Time frame: Pre-dose up to 24 hours post dose on Day 10

  11. Apparent Volume of Distribution During the Terminal Phase of IX-01

    Time frame: Pre-dose up to 96 hours post dose on Day 10

  12. Urine 6-β-hydroxycortisol/cortisol Ratio

    Time frame: Pre-dose on Day 1 and Day 10

  13. IX-01 Concentration and Amount Secreted in Semen

    Time frame: Between 2 and 4 hours after dosing, on Day 9

07

Study locations

1 site
  • Hammersmith Medicines Research (HMR)
    London, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2013
First posted
Nov 25, 2013
Start
Nov 2013
Primary completionActual
Mar 2014
CompletionActual
Mar 2014
Last update
Sep 3, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01994083
Lead sponsor
Ixchelsis Limited
Responsible party
Sponsor
First posted
Nov 25, 2013
Start date
Nov 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Sep 3, 2014

Study contacts

Email: Ixchelsis@Choruspharma.com
study director · Ixchelsis Limited

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: IX-01

Other studies from this sponsor

Ixchelsis Limited

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