HealthyPhase 1IX-0106 RBANCT02962531
Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males
A Phase 1 study testing IX-01 caplets 1600 mg (4 x 400 mg), fasted, IX-01 caplets 1600 mg (4 x 400 mg), fed and IX-01 aqueous dispersion 1600 mg (20 mL), fasted in people with Healthy, run by Ixchelsis Limited at 1 site in United States.
Trial summary
An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01 in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state 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
- What is being tested?
- IX-01 caplets 1600 mg (4 x 400 mg), fasted, IX-01 caplets 1600 mg (4 x 400 mg), fed and IX-01 aqueous dispersion 1600 mg (20 mL), fasted
- 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 States
- Study dates
- Nov 2016to Dec 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
- Body mass index between 18 and 30 kg/m2
- Body weight of ˃60 kg (132 lbs) at screening
- Able to understand the nature of the trial and any hazards of participating. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire trial
- Willing to comply with the contraception requirements of the trial
- Willing to give written consent to participate
- Willing and able to remain in the study unit for the entire duration of each confinement period and return for outpatient visits
- Willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during fed study period
- Vital signs at both screening and at baseline within: heart rate: 50-90 beats per minute; systolic blood pressure: 100-130 mmHg; diastolic: 60-90 mmHg
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at screening that could interfere with the objectives of the trial or safety of the volunteer, including any of the following:
- Lipid and/or liver function test results >1.25 times upper limit of normal or another clinical laboratory result judged clinically significant
- An international normalised ratio of >1.2 or a platelet count <150 x10^3/mL
- History of unexplained syncope
- Family history of unexplained sudden death or sudden death due to long QT syndrome
- QTcF interval >450 msec at screening
Show all 24Show fewer
- Bundle branch block or another conduction abnormality during an ECG, other than mild first degree atrio-ventricular block, judged clinically significant
- Irregular rhythms during an ECG, other than sinus arrhythmia or occasional supraventricular ectopic beats, judged clinically significant
- T-wave configuration of insufficient quality for determination of QT interval, as assessed by ECG and judged clinically significant by the Investigator
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial or make study participation unnecessarily hazardous
- Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, hematological, 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, metabolism, or elimination of medicines
- Presence or history of severe adverse reaction to any drug and/or a history of skin reactions (rashes) to any drug
- Previous allergic response which involved hives, swelling, shortness of breath, or anaphylaxis
- Has used any over-the-counter medications, nutritional or dietary supplements, herbal preparations, or vitamins, except short courses of medication (such as acetaminophen), that could interfere with subject safety or the integrity of the trial data within 7 days prior to the first dose of medication
- Any prescription medication within 14 days prior to the first dose of study medication
- Participation in another clinical trial within 60 days prior to the first dose of study medication
- 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
- Unwilling or unable to comply with all protocol requirements
- Positive urine screen for drugs of abuse
- Positive for hepatitis B surface antigen, hepatitis C antibody or Human Immunodeficiency Virus at screening or previously treated for hepatitis B, hepatitis C, or Human Immunodeficiency Virus infection
- Donated blood or plasma within 30 days prior to the first dose of study medication
- 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 States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: A Randomized, Single-Dose, 3-Way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Caplet Formulation Compared With the IX 01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Caplet Formulation, in Healthy Male Subjects
An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01 in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state
Read the detailed description
This is a Relative Bioavailability Study to compare single oral doses of 1600mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state. Each volunteer in the study will receive each of the formulations listed below. Each formulation will be separated by at least a 5-day drug-free (washout) period.
- Treatment A: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted conditions
- Treatment B: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions
- Treatment C: A single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted conditions.
In the fasted treatment periods, dosing will follow an overnight fast of at least 10 hours.
In the fed treatment period, following an overnight fast of at least 10 hours, a standard high-calorie, high-fat breakfast meal will be given 30 minutes prior to administration of the study drug.
There will be a final follow-up visit 7-10 days after the final dose of study medication.
- Conditions
- Healthy
- Being tested
- IX-01 caplets 1600 mg (4 x 400 mg), fasted, IX-01 caplets 1600 mg (4 x 400 mg), fed, IX-01 aqueous dispersion 1600 mg (20 mL), fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IX-01 caplets 1600 mg (4 x 400 mg), fastedDrug
oral dose under fasted conditions
IX-01 caplets 1600 mg (4 x 400 mg), fedDrug
oral dose under fed conditions
IX-01 aqueous dispersion 1600 mg (20 mL), fastedDrug
oral dose under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted conditions Receives: Drug: IX-01 caplets 1600 mg (4 x 400 mg), fasted |
| Treatment B | Experimental | A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions Receives: Drug: IX-01 caplets 1600 mg (4 x 400 mg), fed |
| Treatment C | Experimental | A single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted conditions. Receives: Drug: IX-01 aqueous dispersion 1600 mg (20 mL), fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter peak plasma concentration of IX-01 (C max)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter time of peak plasma concentration of IX-01 (t max)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter terminal half-life (t 1/2)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter elimination rate constant (K el)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation (fasted)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter area under the concentration-time curve (AUC 0-inf)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
area under the concentration-time curve from 0 up to the time of last quantifiable concentration (AUC last)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
The relative bioavailability of IX-01, as judged by AUC 0-inf (F rel)
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation when administered in the fasted state
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Maximum Plasma Concentration [Cmax] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Area Under the Curve [AUC] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Time to Maximum Plasma Concentration [Tmax] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of the Area Under the Curve [AUC] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Measured: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Secondary outcomes (1)
Safety monitoring - adverse events, laboratory data, ECGs, vital signs
To monitor the safety and tolerability of IX-01
Measured: Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ixchelsis Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962531
- Sponsor's protocol ID
- IX-0106
- Acronym
- IX-0106 RBA
- Status last verified
- Jan 2017
- First submitted
- 24 Oct 2016
- Last updated
- 13 Jan 2017
- 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 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Dose, 3-Way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Caplet Formulation Compared With the IX 01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Caplet Formulation, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02962531
- Acronym / sponsor ID
- IX-0106 RBA / IX-0106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ixchelsis LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 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.
An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01 in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state
Detailed description
This is a Relative Bioavailability Study to compare single oral doses of 1600mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state. Each volunteer in the study will receive each of the formulations listed below. Each formulation will be separated by at least a 5-day drug-free (washout) period.
- Treatment A: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted conditions
- Treatment B: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions
- Treatment C: A single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted conditions.
In the fasted treatment periods, dosing will follow an overnight fast of at least 10 hours.
In the fed treatment period, following an overnight fast of at least 10 hours, a standard high-calorie, high-fat breakfast meal will be given 30 minutes prior to administration of the study drug.
There will be a final follow-up visit 7-10 days after the final dose of study medication.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: IX-01 caplets 1600 mg (4 x 400 mg), fastedA single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted conditions |
| Treatment B | Experimental | Drug: IX-01 caplets 1600 mg (4 x 400 mg), fedA single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions |
| Treatment C | Experimental | Drug: IX-01 aqueous dispersion 1600 mg (20 mL), fastedA single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body mass index between 18 and 30 kg/m2
- Body weight of ˃60 kg (132 lbs) at screening
- Able to understand the nature of the trial and any hazards of participating. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire trial
- Willing to comply with the contraception requirements of the trial
- Willing to give written consent to participate
Key exclusion criteria (24 listed)
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at screening that could interfere with the objectives of the trial or safety of the volunteer, including any of the following:
- Lipid and/or liver function test results >1.25 times upper limit of normal or another clinical laboratory result judged clinically significant
- An international normalised ratio of >1.2 or a platelet count <150 x10^3/mL
- History of unexplained syncope
- Family history of unexplained sudden death or sudden death due to long QT syndrome
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 caplets 1600 mg (4 x 400 mg), fastedoral dose under fasted conditions | Drug | Treatment A |
| IX-01 caplets 1600 mg (4 x 400 mg), fedoral dose under fed conditions | Drug | Treatment B |
| IX-01 aqueous dispersion 1600 mg (20 mL), fastedoral dose under fasted conditions | Drug | Treatment C |
Primary outcome
Pharmacokinetic parameter peak plasma concentration of IX-01 (C max)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Pharmacokinetic parameter time of peak plasma concentration of IX-01 (t max)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Pharmacokinetic parameter terminal half-life (t 1/2)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Pharmacokinetic parameter elimination rate constant (K el)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation (fasted)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Pharmacokinetic parameter area under the concentration-time curve (AUC 0-inf)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
area under the concentration-time curve from 0 up to the time of last quantifiable concentration (AUC last)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
The relative bioavailability of IX-01, as judged by AUC 0-inf (F rel)
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation when administered in the fasted state
Comparison of Maximum Plasma Concentration [Cmax] in fed versus fasted states
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Comparison of Area Under the Curve [AUC] in fed versus fasted states
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Comparison of Time to Maximum Plasma Concentration [Tmax] in fed versus fasted states
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Comparison of the Area Under the Curve [AUC] in fed versus fasted states
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
1 secondary outcome
Safety monitoring - adverse events, laboratory data, ECGs, vital signs
Time frame: Day 0 to Day 21
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 13 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 caplets 1600 mg (4 x 400 mg), fasted, IX-01 caplets 1600 mg (4 x 400 mg), fed and IX-01 aqueous dispersion 1600 mg (20 mL), fasted in people with Healthy, run by Ixchelsis Limited at 1 site in United States.
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 13 Jan 2017. 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 States. 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?
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?
Pharmacokinetic parameter peak plasma concentration of IX-01 (C max) (time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose). The study lists 12 primary outcomes in all. 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 13 Jan 2017.