Study of APD421 With and Without Ondansetron

• Sponsor: Acacia Pharma Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03583489
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Days): 27
• Patients Per Site Per Month: 33.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jul 17, 2018
• Actual Primary Completion Date: Aug 13, 2018
• Actual Study Completion Date: Aug 13, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ddQTcF [0-6 hours]

   Placebo-corrected change-from-baseline QTcF interval

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. 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

1. Positive drugs of abuse test result

2. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening

3. 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

4. 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

5. Failure to satisfy the investigator of fitness to participate for any other reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Early Phase Clinical Unit	London		United Kingdom

Sponsors and Collaborators

• Acacia Pharma Ltd

Investigators

• Principal Investigator: Muna Albayaty, Early Phase Clinical Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acacia Pharma Ltd
• ClinicalTrials.gov Identifier: NCT03583489
• Other Study ID Numbers: DP10022
• First Posted: Jul 11, 2018
• Last Update Posted: Oct 1, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting; Ondansetron

Study Results

No Results Posted as of Oct 1, 2018