Postoperative Nausea and VomitingPhase 1NCT03583489
Study of APD421 With and Without Ondansetron
A Phase 1 study testing APD421 and Ondansetron in people with Postoperative Nausea and Vomiting, run by Acacia Pharma Ltd at 1 site in United Kingdom.
Trial summary
Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given APD421 +/- ondansetron Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- APD421 and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2018to 13 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age 18 to 65 years of age at time of signing ICF
- Body mass index (BMI) of 18 to 30 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 3 months prior to IMP administration on this study
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- Women who are pregnant or breastfeeding
- Subjects who have received amisulpride for any indication within the previous 4 weeks
- Allergy to amisulpride or any of the excipients of APD421 or ondansetron
Show all 33Show fewer
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products (current smoking may be assessed by a validated technique such as urine or serum cotinine levels)
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- History of epilepsy
- History of clinically significant syncope
- Family history of sudden death
- Family history of premature cardiovascular death
- Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome
- History of clinically significant arrhythmias or ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm)
- Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa)
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- This includes subjects with any of the following at screening:
- Absence of regular supraventricular rhythm
- Clinically significant PR (PQ) interval prolongation
- Intermittent second or third degree AV block
- Incomplete or complete bundle branch block.
- Abnormal T-wave morphology
- Prolonged QTcB >450 ms or shortened QTcB < 350 ms or family history of long QT syndrome Subject with borderline deviations from these criteria may be included if the deviations do not pose a safety risk, as judged by the investigator
- Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator, especially:
- Creatinine clearance (estimated using Cockcroft-Gault formula) < 60 mL/min
- Alanine aminotransferase (ALT) > 1.5 x upper limit of normal or bilirubin > 3 x upper limit of normal
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening
- Donation or loss of greater than 100 mL of blood within the 3 months prior to screening or planned blood donation during the study until after final visit
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Crossover Study in Healthy Adult Subjects to Investigate the Effect of Intravenous APD421, With and Without Ondansetron, on Cardiac Conduction
Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given APD421 +/- ondansetron
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- APD421, Placebo, Ondansetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD421Drug
10 mg IV
PlaceboDrug
IV
OndansetronDrug
4 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| APD421 | Experimental | Not described Receives: Drug: APD421 |
| APD421 + ondansetron | Experimental | Not described Receives: Drug: APD421; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
ddQTcF
Placebo-corrected change-from-baseline QTcF interval
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start17 Jul 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acacia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, Principal investigator, Early Phase Clinical Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583489
- Sponsor's protocol ID
- DP10022
- Status last verified
- Sep 2018
- First submitted
- 28 Jun 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fox GM, Albayaty M, Walker JL, Xue H, Darpo B. Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2021 Jan;132(1):150-159. doi: 10.1213/ANE.0000000000004538.
PubMed 31913911
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Crossover Study in Healthy Adult Subjects to Investigate the Effect of Intravenous APD421, With and Without Ondansetron, on Cardiac Conduction
- ClinicalTrials.gov ID
- NCT03583489
- Acronym / sponsor ID
- DP10022
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acacia Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 11 Jul 2018 (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.
Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given APD421 +/- ondansetron
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| APD421 | Experimental | Drug: APD421 |
| APD421 + ondansetron | Experimental | Drug: APD421, Drug: Ondansetron |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects
- Age 18 to 65 years of age at time of signing ICF
- Body mass index (BMI) of 18 to 30 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (33 listed)
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 3 months prior to IMP administration on this study
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- Women who are pregnant or breastfeeding
- Subjects who have received amisulpride for any indication within the previous 4 weeks
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 |
|---|---|---|
| APD42110 mg IV | Drug | APD421, APD421 + ondansetron |
| PlaceboIV | Drug | Placebo |
| Ondansetron4 mg IV | Drug | APD421 + ondansetron |
Primary outcome
ddQTcF
Time frame: 0-6 hours
Placebo-corrected change-from-baseline QTcF interval
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 1 Oct 2018.
- Derived from this study: PubMed 31913911Fox GM, Albayaty M, Walker JL, Xue H, Darpo B. Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2021 Jan;132(1):150-159. doi: 10.1213/ANE.0000000000004538.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
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PONV
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Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
Muna Albayaty principal investigator
Early Phase Clinical Unit
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 APD421 and Ondansetron in people with Postoperative Nausea and Vomiting, run by Acacia Pharma Ltd 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 33 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 1 Oct 2018. 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. 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 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?
ddQTcF (time frame: 0-6 hours). 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 NCT03583489, which also lists 1 linked publication.
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 1 Oct 2018.