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Study of APD421 With and Without Ondansetron

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583489
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Brief Summary:
Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given APD421 +/- ondansetron

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: APD421 Drug: Placebo Drug: Ondansetron Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
IV

Experimental: APD421 Drug: APD421
10 mg IV

Experimental: APD421 + ondansetron Drug: APD421
10 mg IV

Drug: Ondansetron
4 mg IV




Primary Outcome Measures :
  1. ddQTcF [ Time Frame: 0-6 hours ]
    Placebo-corrected change-from-baseline QTcF interval



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subjects
  2. Age 18 to 65 years of age at time of signing ICF
  3. Body mass index (BMI) of 18 to 30 kg/m2
  4. Must be willing and able to communicate and participate in the whole study
  5. Must provide written informed consent
  6. Must agree to use an adequate method of contraception

Exclusion Criteria:

  1. 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
  2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  3. Subjects who have previously been enrolled in this study
  4. Women who are pregnant or breastfeeding
  5. Subjects who have received amisulpride for any indication within the previous 4 weeks
  6. Allergy to amisulpride or any of the excipients of APD421 or ondansetron
  7. History of any drug or alcohol abuse in the past 2 years
  8. Regular alcohol consumption >21 units per week
  9. 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)
  10. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  11. History of epilepsy
  12. History of clinically significant syncope
  13. Family history of sudden death
  14. Family history of premature cardiovascular death
  15. 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
  16. History of clinically significant arrhythmias or ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm)
  17. Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa)
  18. 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
  19. 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
  20. Positive drugs of abuse test result
  21. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening
  22. 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
  23. 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
  24. Failure to satisfy the investigator of fitness to participate for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583489


Locations
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United Kingdom
Early Phase Clinical Unit
London, United Kingdom
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
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Principal Investigator: Muna Albayaty Early Phase Clinical Unit

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Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT03583489     History of Changes
Other Study ID Numbers: DP10022
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents