Irritable Bowel SyndromePhase 1NCT04655599
Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
A Phase 1 study testing Olorinab in people with Irritable Bowel Syndrome, run by Arena Pharmaceuticals at 1 site in United States.
Trial summary
A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Olorinab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2021to 13 Apr 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or IBS with predominant diarrhea (IBS-D) according to Rome IV criteria at Screening
- Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive at Screening
- Negative test results for alcohol and selected drugs at Screening and Day 1
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening
- Participants with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for participants with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS
Who cannot join
- Pregnant or lactating
- Structural or metabolic diseases/conditions that affect the gastrointestinal system
- Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
- Unable to withdraw medications that alter gastrointestinal (GI) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide)
- Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
Trial locations and contacts
1 site in 1 country.
About this study
A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).
Read the detailed description
This is a single-center, randomized, crossover, double-blind, placebo-controlled study designed to evaluate the effects of olorinab on gastric, small-bowel, and colonic transit in IBS participants with predominant constipation (IBS-C) or with predominant diarrhea (IBS-D).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Olorinab, Placebo
- Keywords
- Olorinab, APD371, Irritable bowel syndrome, IBS, IBS with predominant constipation, IBS-C, IBS with predominant diarrhea, IBS-D
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlorinabDrug
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
PlaceboDrug
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
| Study group | Role | What they receive |
|---|---|---|
| Olorinab, Then Placebo | Experimental | Participants will first receive olorinab, followed by a washout period, and they then will receive placebo. Receives: Drug: Olorinab; Drug: Placebo |
| Placebo, Then Olorinab | Placebo comparator | Participants will first receive placebo, followed by a washout period, and they then will receive olorinab. Receives: Drug: Olorinab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Measured: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
Measured: up to 4 hours 10 minutes after consumption of radiolabeled meal
Secondary outcomes (4)
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Measured: up to 48 hours 30 minutes after consumption of radiolabeled meal
Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule
Measured: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying after radiolabeled meal
Measured: at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
Number and severity of adverse events
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Measured: Up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start29 Jan 2021
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Why it stopped: Strategic business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arena CT.gov Administrator, Study director, Arena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655599
- Sponsor's protocol ID
- APD371-106
- Status last verified
- May 2021
- First submitted
- 19 Nov 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04655599
- Acronym / sponsor ID
- APD371-106
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Olorinab, APD371, Irritable bowel syndrome, IBS, IBS with predominant constipation, IBS-C, IBS with predominant diarrhea, IBS-D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- 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 Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).
Detailed description
This is a single-center, randomized, crossover, double-blind, placebo-controlled study designed to evaluate the effects of olorinab on gastric, small-bowel, and colonic transit in IBS participants with predominant constipation (IBS-C) or with predominant diarrhea (IBS-D).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olorinab, Then Placebo | Experimental | Drug: Olorinab, Drug: PlaceboParticipants will first receive olorinab, followed by a washout period, and they then will receive placebo. |
| Placebo, Then Olorinab | Placebo comparator | Drug: Olorinab, Drug: PlaceboParticipants will first receive placebo, followed by a washout period, and they then will receive olorinab. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or IBS with predominant diarrhea (IBS-D) according to Rome IV criteria at Screening
- Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive at Screening
- Negative test results for alcohol and selected drugs at Screening and Day 1
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening
- Participants with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for participants with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS
Key exclusion criteria (5 listed)
- Pregnant or lactating
- Structural or metabolic diseases/conditions that affect the gastrointestinal system
- Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
- Unable to withdraw medications that alter gastrointestinal (GI) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide)
- Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
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 |
|---|---|---|
| OlorinabOlorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5. | Drug | Olorinab, Then Placebo, Placebo, Then Olorinab |
| PlaceboOlorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5. | Drug | Olorinab, Then Placebo, Placebo, Then Olorinab |
Primary outcome
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Time frame: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
Time frame: up to 4 hours 10 minutes after consumption of radiolabeled meal
4 secondary outcomes
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Time frame: up to 48 hours 30 minutes after consumption of radiolabeled meal
Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule
Time frame: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying after radiolabeled meal
Time frame: at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
Number and severity of adverse events
Time frame: Up to approximately 6 weeks
Results and safety
The study was stopped early (reason given: Strategic business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- 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.
Arena CT.gov Administrator study director
Arena Pharmaceuticals
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 Olorinab in people with Irritable Bowel Syndrome, run by Arena Pharmaceuticals 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 5 inclusion and 5 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 17 May 2021. 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. 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: Strategic business decision). 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?
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule (time frame: up to 24 hours 30 minutes after consumption of radiolabeled meal). The study lists 2 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 17 May 2021.