N/A as the study is in healthy volunteers
Conditions
Interventions
Not applicable.
Sponsors
FORUM Pharmaceuticals Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. ICF signed by the subject or legally acceptable representative before any study-specific procedures for the subject are performed. 2. Healthy males and females >=65 and =18 and 27. 7. Fertile, sexually active male subjects must use an effective method of contraception during the study. The female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal occlusion/ligation), postmenopausal for at least 1 year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method]). 8. Able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff. 9. Willing and able to comply with study restrictions (Section 8.3).
Exclusion criteria
Exclusion criteria: 1. History or presence of any clinically significant illness that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. 2. Presence (at Screening or Day -1 of Period 1) of abnormal laboratory or ECG results, vital signs, or physical findings that are considered clinically relevant by the investigator. 3. Positive test for hepatitis B, hepatitis C, or HIV. 4. History of alcoholism or substance abuse within 3 years prior to Screening. 5. Hemoglobin value of 1.5 times the upper limit of normal (ULN) at Screening. 7. Evidence of potential significant renal insufficiency, indicated by a serum creatinine value >178 µmol/L at Screening. 8. Evidence of elevated blood pressure >160 mmHg systolic or >100 mmHg diastolic at Screening or Baseline. 9. Presence at Screening of any clinically significant cardiac abnormalities including, but not limited to, patterns consistent with myocardial ischemia, electrolyte abnormalities, atrial or ventricular dysrhythmia or significant conduction abnormalities, or a corrected QT interval using Fridericia*s formula (QTcF) of >450 msec for males and >470 msec for females. 10. Habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at Screening and/or is not able to refrain from use of (methyl) xanthines (eg, coffee, tea, cola, chocolate) from 12 hours prior to dosing on Day 1 until discharge from the CRU for each study period. 11. Positive drug screen (including cotinine UDS and breath alcohol test) at Screening and/or Day -1 of Period 1. 12. History of severe allergies, an anaphylactic reaction to prescription or non-prescription drugs or food, or an allergic reaction to nicotine-containing products. 13. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drugs (EVP-6124 or scopolamine). 14. Significant suicide risk as defined by: suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or baseline; or, suicidal behaviors within 1 year before screening. 15. Participated in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug (Day 1 Period 1). 16. Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines of approximately 500 mL or significant blood loss within 3 months prior to Screening. 17. Donation of plasma in a plasmapheresis program within 7 days prior to Screening. 18. Received treatment with other nicotinic receptor agonists (eg, varenicline) within 3 months of Screening. 19. Veins unsuitable for cannula placement on both arms. 20. An employee of the Sponsor or CRU personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: Adaptive Tracking Test, Finger Tapping Test, N-back test, Milner maze test, Visual Verbal Learning Test, Saccadic Eye Movement testing, Pupil / iris ratio measurement, EEG and auditory Event-Related Potential tests. Inflammatory ex vivo challenge: different cytokines. Pharmacokinetics: PK plasma samples of scopolamine, EVP-6124 and metabolites. Safety and tolerability: adverse events, clinical chemistry, hematology, urine tests, heart and respiratory rate, blood pressure, temperature, ECG, physical examination, and various questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed