DyspepsiaPhase 1NCT02875678
A Study to Evaluate the Effects of ABX-1431 on Patients With Functional Dyspepsia
A Phase 1 study testing ABX-1431 in people with Dyspepsia, run by Abide Therapeutics at 1 site in Belgium.
Trial summary
A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients with Functional Dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- ABX-1431
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2016to 7 Aug 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has functional dyspepsia, postprandial distress syndrome (PDS) subtype, defined by the Rome III criteria.
- Patient has evidence of impaired gastric accommodation.
- Patient's Rome III Questionnaire results indicates that the intensity of co-existing epigastric pain and/or epigastric burning may be present, but have the same or lesser intensity than the evaluations of postprandial fullness or early satiety (i.e. epigastric pain and burning are not the prominent symptoms of the patient's functional dyspepsia).
- Patient recall of symptoms of gastrointestinal reflux over the past 8 weeks has no more than 2 episodes per week of heartburn or regurgitation.
- Patient is a male or female between 18 and 65 years of age at the pre-study/screening visit.
- Patient has a Body Mass Index (BMI) >18 to ≤30 kg/m2 at the pre-study/screening visit.
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- Patient is judged to have no unmanaged significant disease or disorder based on medical history, physical examination, vital sign measurements, and laboratory safety obtained at pre-study/screening, and within 36 hours prior to first administration of study drug.
- Patient has no clinically significant abnormality of ECG performed at pre study/screening, and prior to first administration of study drug.
- Patient is willing to undergo the nutrient volume tolerance tests.
Who cannot join
- Patient is under the age of legal consent.
- Female patients who are pregnant or breastfeeding.
- Patient has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, anxiety disorder, post-traumatic stress disorder, psychotic disorder or drug-induced psychoses).
- Patient has a first-degree family history of schizophrenia, severe affective disorder, severe anxiety disorder, or other psychosis.
- Patient is taking antidepressants including SSRIs, SNRIs, tricyclic antidepressants, or atypical antidepressant medications such as bupropion, mirtazapine, trazodone or agomelatine. Patients taking these or other types of medicine for anxiety are also excluded. Patients who have discontinued antidepressants more than 6 months ago may be enrolled at the discretion of the Investigator. Patients who are taking gabapentin or pregabalin or buspirone are also excluded.
- Patient is mentally or legally incapacitated, has significant emotional problems at the time of pre-study/screening visit or is expected to have potential for mental incapacitation during the conduct of the study.
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- Patient has had any gastrointestinal surgery. Those having undergone a simple appendectomy more than 1 year prior to the pre-study/screening visit may participate.
- Patient has had any acute gastrointestinal illness in the past 3 months.
- Patient has laboratory tests at screening or within 36 hours of first administration of study drug outside of these limits: Aspartate transaminase (AST) >1.5 x upper limit of normal (ULN) or Alanine transaminase (ALT) >1.5 x ULN.
- Patient has an estimated creatinine clearance (CrCl) of ≤80 mL/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as measured using a 24-hour urine collection, may be used in place of, or in conjunction with the Cockcraft-Gault calculation. Patients with an actual or calculated creatinine clearance that is in the range of 72-79 mL/min (i.e., within 10% of 80 mL/min) may be enrolled in the study at the discretion of the Investigator.
- Patient has an active or prior history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (>10 minutes), or migraine headaches.
- Patient has a history of clinically significant neoplastic disease, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin (e.g., basal cell carcinoma) or the cervix.
- Patient has a family history of long QT syndrome.
- Patient has a QTc interval of >450 msec (male patients) or >470 msec (female patients).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients With Functional Dyspepsia
A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients with Functional Dyspepsia.
Read the detailed description
This is a single dose, randomized, placebo-controlled, two period crossover study. This study will assess the effects of ABX-1431 on gastric physiology in patients with functional dyspepsia, who have clinical evidence of impaired gastric accommodation with meals.
All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with a single dose of ABX-1431 HCl or placebo followed by IGP measurement, measured with a high resolution manometry probe during a nutrient volume tolerance test. After a washout period of at least one week, patients will undergo identical procedures with the other treatment.
This study will enroll 12 functional dyspepsia (FD) patients.
- Conditions
- Dyspepsia
- Being tested
- ABX-1431, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-1431Drug
Single-dose ABX-1431
PlaceboDrug
Single-dose matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ABX-1431 | Experimental | ABX-1431, capsules, 40 mg, single dose Receives: Drug: ABX-1431 |
| Placebo | Placebo comparator | Placebo, capsules, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from placebo in area above the curve of intragastric pressure (mm Hg) during a liquid meal infusion on Day 1
Measured: Through Day 1 of dosing
Secondary outcomes (1)
Difference from placebo in nutrient volume tolerance (ml) on Day 1 placebo.
Measured: Through Day 1 of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start22 Nov 2016
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abide Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chan Beals, MD,PhD, Study director, Abide Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875678
- Sponsor's protocol ID
- ABX-1431_PN005
- Status last verified
- Sep 2017
- First submitted
- 13 Jul 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02875678
- Acronym / sponsor ID
- ABX-1431_PN005
- Conditions
- Dyspepsia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Abide TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 23 Aug 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.
A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients with Functional Dyspepsia.
Detailed description
This is a single dose, randomized, placebo-controlled, two period crossover study. This study will assess the effects of ABX-1431 on gastric physiology in patients with functional dyspepsia, who have clinical evidence of impaired gastric accommodation with meals.
All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with a single dose of ABX-1431 HCl or placebo followed by IGP measurement, measured with a high resolution manometry probe during a nutrient volume tolerance test. After a washout period of at least one week, patients will undergo identical procedures with the other treatment.
This study will enroll 12 functional dyspepsia (FD) patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABX-1431 | Experimental | Drug: ABX-1431ABX-1431, capsules, 40 mg, single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, capsules, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has functional dyspepsia, postprandial distress syndrome (PDS) subtype, defined by the Rome III criteria.
- Patient has evidence of impaired gastric accommodation.
- Patient's Rome III Questionnaire results indicates that the intensity of co-existing epigastric pain and/or epigastric burning may be present, but have the same or lesser intensity than the evaluations of postprandial fullness or early satiety (i.e. epigastric pain and burning are not the prominent symptoms of the patient's functional dyspepsia).
- Patient recall of symptoms of gastrointestinal reflux over the past 8 weeks has no more than 2 episodes per week of heartburn or regurgitation.
- Patient is a male or female between 18 and 65 years of age at the pre-study/screening visit.
Key exclusion criteria (14 listed)
- Patient is under the age of legal consent.
- Female patients who are pregnant or breastfeeding.
- Patient has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, anxiety disorder, post-traumatic stress disorder, psychotic disorder or drug-induced psychoses).
- Patient has a first-degree family history of schizophrenia, severe affective disorder, severe anxiety disorder, or other psychosis.
- Patient is taking antidepressants including SSRIs, SNRIs, tricyclic antidepressants, or atypical antidepressant medications such as bupropion, mirtazapine, trazodone or agomelatine. Patients taking these or other types of medicine for anxiety are also excluded. Patients who have discontinued antidepressants more than 6 months ago may be enrolled at the discretion of the Investigator. Patients who are taking gabapentin or pregabalin or buspirone are also excluded.
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 |
|---|---|---|
| ABX-1431Single-dose ABX-1431 | Drug | ABX-1431 |
| PlaceboSingle-dose matching placebo | Drug | Placebo |
Primary outcome
Difference from placebo in area above the curve of intragastric pressure (mm Hg) during a liquid meal infusion on Day 1
Time frame: Through Day 1 of dosing
1 secondary outcome
Difference from placebo in nutrient volume tolerance (ml) on Day 1 placebo.
Time frame: Through Day 1 of dosing
Results and safety
The study was stopped early (reason given: recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Chan Beals, MD,PhD study director
Abide Therapeutics
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 ABX-1431 in people with Dyspepsia, run by Abide Therapeutics at 1 site in Belgium.
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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Sep 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 Belgium. 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 was stopped early (reason given: recruitment challenges). Results are not available in the source record.
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?
Difference from placebo in area above the curve of intragastric pressure (mm Hg) during a liquid meal infusion on Day 1 (time frame: Through Day 1 of dosing). 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 7 Sep 2017.