NCT03583489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

27 days

First QC Date

June 28, 2018

Last Update Submit

September 28, 2018

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • ddQTcF

    Placebo-corrected change-from-baseline QTcF interval

    0-6 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

APD421

EXPERIMENTAL
Drug: APD421

APD421 + ondansetron

EXPERIMENTAL
Drug: APD421Drug: Ondansetron

Interventions

APD421DRUG

10 mg IV

APD421APD421 + ondansetron
PlaceboDRUG

IV

Placebo
OndansetronDRUG

4 mg IV

APD421 + ondansetron

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Phase Clinical Unit

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31913911DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Muna Albayaty

    Early Phase Clinical Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

July 17, 2018

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

October 1, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)