Healthy VolunteersPhase 1NCT02792647
A Study of Multiple Oral Doses of IX-01 in Healthy Male Subjects
A Phase 1 study testing IX-01 in people with Healthy Volunteers, 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 the PK of IX-01 and activity of CYP3A4. 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 Volunteers
- 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
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Oct 2016
- 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
- Male healthy volunteer.
- Aged 18-45 years at the time of signing the informed consent.
- A body mass index (Quetelet index) in the range 18-30.
- Total body weight >50 kg at screening.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to comply with the contraception requirements of the trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer, including any of the following findings:
- have lipid and/or liver function test results >1.25 x ULN or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor
- history of unexplained syncope
- family history of unexplained sudden death, or sudden death due to long QT syndrome
- QTcF interval >450 msec in 2 of 3 consecutive ECGs (additional ECGs may be recorded, if required, but a median QTcF ≤ 450 msec from 3 consecutive ECGs is required for the volunteer to be considered eligible)
- bundle branch block and other conduction abnormalities, other than mild first degree atrio-ventricular block
Show all 24Show fewer
- irregular rhythms other than sinus arrhythmia or occasional supraventricular ectopic beats
- T-wave configuration of insufficient quality for determination of QT interval, as assessed by the investigator
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's 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 (e.g. stomach bypass) or medical condition that might affect absorption 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 subject 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 3 months prior to the first dose.
- 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 mm Hg systolic, 50-90 mm Hg diastolic; heart rate 50-90 beats/min, unless judged not clinically significant by an investigator.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Evidence of drug abuse on urine testing.
- Positive test for hepatitis B, hepatitis C or HIV1 or HIV2.
- Loss of more than 400 mL blood during the 3 months prior to the first dose, eg as a blood donor.
- Objection by General Practitioner (GP) to volunteer entering trial.
- Employee of the investigator site or any company involved in sponsoring, organising or conducting the trial, or immediate family of the employee. Immediate family is defined as spouse, parent, child or sibling, whether biologically related or legally adopted.
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, Toleration, 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 the PK of IX-01 and activity of CYP3A4.
- Conditions
- Healthy Volunteers
- 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 |
| Experimental: IX-01 | Experimental | 2 different dose groups 1,600 mg and 2,400 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 (12)
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
Urine 6-β-hydroxycortisol/cortisol Ratio
Measured: Pre-dose on Day 1 and Day 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ixchelsis Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franz van den Berg, MBChB, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792647
- Sponsor's protocol ID
- IX-0104
- Status last verified
- Nov 2016
- First submitted
- 2 Jun 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. 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, Toleration, and Pharmacokinetics of Multiple Oral Doses of IX-01 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02792647
- Acronym / sponsor ID
- IX-0104
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ixchelsis LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Jun 2016 (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 the PK of IX-01 and activity of CYP3A4.
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 |
| Experimental: IX-01 | Experimental | Drug: IX-012 different dose groups 1,600 mg and 2,400 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 (8 listed)
- Male healthy volunteer.
- Aged 18-45 years at the time of signing the informed consent.
- A body mass index (Quetelet index) in the range 18-30.
- Total body weight >50 kg at screening.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
Key exclusion criteria (24 listed)
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer, including any of the following findings:
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's 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 (e.g. stomach bypass) or medical condition that might affect absorption 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 | Experimental: 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)
12 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
Urine 6-β-hydroxycortisol/cortisol Ratio
Time frame: Pre-dose on Day 1 and Day 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
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 10 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Franz van den Berg, MBChB principal investigator
Hammersmith Medicines Research
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 Volunteers, 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 8 inclusion and 24 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 10 Nov 2016. 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 10 Nov 2016.