A First-in-human Explorative Pilot Study in Healthy Volunteers Measuring Eye Parameters With a New Mobile Phone Application for Future Monitoring of Patients in Treatment of Substance Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Drug Abuse
- Sponsor
- Kontigo Care AB
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
Detailed Description
This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female healthy volunteers
- •Age 18 to 70 years
- •BMI between 18.5-30 kg/m2
- •Weight between 50-100 kg
- •Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollment
- •Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until study completion
- •No current drug usage defined as a negative urine drug test at enrollment and at visit 2
- •Able to use Previct Drugs after initial training (defined as successfully performing a test after trying maximum three times per measurement)
- •Been informed of the nature, the scope, and the relevance of the clinical investigation
- •Voluntarily agreed on participation and has duly singed the Informed Consent Form
Exclusion Criteria
- •Participating in another clinical investigation which may affect the study outcome according to clinical judgement
- •Pregnancy or Lactating
- •Abnormal ECG (QTc time \>450 ms) at enrollment
- •Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse
- •Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgement
- •Any disease or condition that may influence pupillary reflexes based on clinical judgement
- •Undergone eye surgery that may influence pupillary reflexes based on clinical judgement
- •Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement
- •Ongoing treatment with medications which may interfere with any of the medicinal products to be used
- •History or presence of allergy or serious reaction to the medicinal products to be used
Outcomes
Primary Outcomes
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Time Frame: Day 7 +/- 2 days (Visit 2)
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt".
Secondary Outcomes
- Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition.(Day 7 +/- 2 days (Visit 2))
- Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).(Day 7 +/- 2 days (Visit 2))
- Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.(Day 7 +/- 2 days (Visit 2))
- Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.(Day 7 +/- 2 days (Visit 2))
- Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 1(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 2(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 4(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 5(Day 7 +/- 2 days (Visit 2))
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- Usability Questionnaire - Question 8(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 9(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 10(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 11(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 12(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 13(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 15(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 16(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 18(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 20(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 21(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 23(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 24(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 26(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 27(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 29(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 31(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 33(Day 7 +/- 2 days (Visit 2))
- Usability Questionnaire - Question 34(Day 7 +/- 2 days (Visit 2))