- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875678
A Study to Evaluate the Effects of ABX-1431 on 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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABX-1431
ABX-1431, capsules, 40 mg, single dose
|
Single-dose ABX-1431
|
Placebo Comparator: Placebo
Placebo, capsules, single dose
|
Single-dose matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Through Day 1 of dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference from placebo in nutrient volume tolerance (ml) on Day 1 placebo.
Time Frame: Through Day 1 of dosing
|
Through Day 1 of dosing
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chan Beals, MD,PhD, Abide Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABX-1431_PN005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyspepsia
-
King Chulalongkorn Memorial HospitalRecruiting
-
Wuhan Central HospitalNot yet recruiting
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Zeria PharmaceuticalRecruitingFunctional DyspepsiaJapan
-
Hong Kong Baptist UniversityXiyuan Hospital of China Academy of Chinese Medical SciencesRecruitingFunctional DyspepsiaHong Kong
-
Seoul National University HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Wonju Severance Christian HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.CompletedFunctional DyspepsiaKorea, Republic of
Clinical Trials on ABX-1431
-
Abide TherapeuticsCogState Ltd.; FGK Clinical Research GmbH; BASi (Bioanalytical Systems, Inc.)CompletedTourette Syndrome | Motor Tic DisorderGermany, Poland, Spain
-
Abide TherapeuticsUniversity of OxfordCompleted
-
Abide TherapeuticsCompletedDiabetic Peripheral Neuropathy | Small Fiber Neuropathy | Post Herpetic Neuralgia | Post-Traumatic NeuralgiaMoldova, Republic of
-
Abide TherapeuticsCompletedMultiple Sclerosis | Neuromyelitis Optica Spectrum Disorder | Transverse Myelitis | Longitudinally Extensive Transverse MyelitisUnited Kingdom
-
Abide TherapeuticsCompletedTourette Syndrome | Chronic Motor Tic DisorderGermany
-
Abalonex, LLCNot yet recruitingTraumatic Brain Injury | Cerebral Edema
-
AmgenCompletedNeoplasm Metastasis | Lung Cancer | Non-small Cell Lung Cancer
-
Eben RosenthalNational Cancer Institute (NCI)RecruitingPancreatic AdenocarcinomaUnited States
-
AbgenixImmunex CorporationCompletedProstate CancerUnited States