Healthy ParticipantsPhase 1NCT02139826

Relative Bioavailability and Food Effect Study of IX-01 Capsules 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men. 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?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited Kingdom
Study dates: May 2014to Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 kilograms/meters squared (kg/m2)
Body Mass Index = weight [kg] divided by (height [m])2
Total body weight greater than (>)50 kg at screening
Ability 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 to comply with the contraception requirements during the trial and for 4 months after the last dose of medication
Willingness to give written consent to have data entered into The Over Volunteering Prevention System

Who cannot join

Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment, including:
Lipid and/or liver function test results >1.25 x Upper Limit of Normal (ULN) or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor
International normalised ratio (INR) of >1.2 or a platelet count < 150 x 109/Liter
History of unexplained syncope
Family history of unexplained sudden death, or sudden death due to long QT syndrome
Fridericia Correction Formula (QTcF) interval >450 milliseconds (msec) at screening

Show all 26Show fewer

Bundle branch block and other conduction abnormalities, other than mild first degree atrio-ventricular block
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 participation in the trial
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
Any skin condition, abnormality of the lumbar spine, medical or surgical condition that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection, left ventricular outflow obstruction, aortic stenosis, previous back surgery)
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 100-130 millimeters of mercury (mm Hg) systolic, 60-90 mm Hg diastolic; heart rate 50-100 beats/minute. Measurements must be made in duplicate, and all values must fall within the acceptable ranges
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 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
Employee of the investigator site or any company involved in sponsoring, organizing or conducting the trial, or immediate family of the employee

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Medicines Research
London

Other trials in United Kingdom

About this study

Official title: A Randomised, Single-dose, 3-way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Capsule Formulation Compared With the IX-01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Capsule Formulation, in Healthy Male Subjects

The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.

Conditions: Healthy Participants
Being tested: IX-01

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IX-01Drug

Study groups in NCT02139826
Study group	Role	What they receive
IX-01 Capsule while Fasting	Experimental	Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods Receives: Drug: IX-01
IX-01 Aqueous Dispersion while Fasting	Experimental	Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods Receives: Drug: IX-01
IX-01 Capsule after Food	Experimental	Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods Receives: Drug: IX-01

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Measured: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Measured: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Measured: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Measured: Pre-dose up to 96 hours post dose
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
Measured: Pre-dose and up to 96 hours post dose
Peak Plasma Concentration (Cmax) of IX-01
Measured: Pre-dose and up to 96 hours post dose
Time to Peak Plasma Concentration (Tmax) of IX-01
Measured: Pre-dose up to 96 hours post dose
Elimination Half Life (t1/2) of IX-01
Measured: Pre-dose up to 96 hours post dose
Elimination Rate Constant (Kel) of IX-01
Measured: Pre-dose up to 96 hours post last dose
Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
Measured: Pre-dose to the time of the last measurable sample
Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Listed by time point of 1, 2, 4, 6 hours post dose
Measured: 1, 2, 4 and 6 hours after dosing

Secondary outcomes (1)

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
Measured: Baseline to study completion (approximately 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2014

First posted15 May 2014 (estimated)
Study startMay 2014
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02139826
Sponsor's protocol ID: IX-0102
Status last verified: Aug 2020
First submitted: 12 May 2014
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-dose, 3-way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Capsule Formulation Compared With the IX-01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Capsule Formulation, in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02139826
Acronym / sponsor ID: IX-0102
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Ixchelsis LimitedIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 15 May 2014 (estimated)
Results: Posted 20 Aug 2020

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 compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
IX-01 Capsule while Fasting	Experimental	Drug: IX-01Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods
IX-01 Aqueous Dispersion while Fasting	Experimental	Drug: IX-01Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods
IX-01 Capsule after Food	Experimental	Drug: IX-01Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods

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 kilograms/meters squared (kg/m2)
Body Mass Index = weight [kg] divided by (height [m])2
Total body weight greater than (>)50 kg at screening
Ability 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 to comply with the contraception requirements during the trial and for 4 months after the last dose of medication

Key exclusion criteria (26 listed)

Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment, including:
Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial
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
Any skin condition, abnormality of the lumbar spine, medical or surgical condition that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection, left ventricular outflow obstruction, aortic stenosis, previous back surgery)

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
IX-01	Drug	IX-01 Aqueous Dispersion while Fasting, IX-01 Capsule after Food, IX-01 Capsule while Fasting

Primary outcome

Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Peak Plasma Concentration (Cmax) of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Time to Peak Plasma Concentration (Tmax) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Half Life (t1/2) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Rate Constant (Kel) of IX-01
Time frame: Pre-dose up to 96 hours post last dose
Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
Time frame: Pre-dose to the time of the last measurable sample
Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Time frame: 1, 2, 4 and 6 hours after dosing
Listed by time point of 1, 2, 4, 6 hours post dose

1 secondary outcome

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline to study completion (approximately 6 weeks)

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	12	11

Primary outcome: Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity

Time frame: Pre-dose up to 96 hours post dose. Geometric mean (90% Confidence Interval). Unit: Ratio: capsule fasted/acqueous fasted

Measure	IX-01 Capsule While Fasting n = 11
Value	99.93 (90.8 to 109.98)

Primary outcome: Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity

Time frame: Pre-dose up to 96 hours post dose. Geometric mean (90% Confidence Interval). Unit: Ratio: capsule fed/fasted

Measure	IX-01 Capsule After Food n = 11
Value	148.85 (135.25 to 163.82)

Primary outcome: Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations

Time frame: Pre-dose up to 96 hours post dose. Geometric mean (90% Confidence Interval). Unit: Ratio: capsule/aqueous

Measure	IX-01 Capsule While Fasting n = 11
Value	123.78 (96.76 to 158.36)

Primary outcome: Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations

Time frame: Pre-dose up to 96 hours post dose. Geometric mean (90% Confidence Interval). Unit: Ratio: capsule fed/fasting

Measure	IX-01 Capsule After Food n = 11
Value	175.46 (137.15 to 224.47)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IX-01 Aqueous Dispersion While Fasting	0 of 11 (0%)	8 of 11 (72.7%)	Not reported
IX-01 Capsule While Fasting	0 of 11 (0%)	3 of 11 (27.3%)	Not reported
IX-01 Capsule After Food	0 of 12 (0%)	4 of 12 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 26 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 20 Aug 2020. 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. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (time frame: Pre-dose up to 96 hours post dose). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02139826.

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 20 Aug 2020.