None listed
Conditions
Interventions
Intervention1: Yohimbine: Yohimbine 0.4 mg/kg, 5 mg tablet administered once as per randomization schedule.
Control Intervention1: Placebo: Oral administration (tablet) administered once as per random
Sponsors
BioXcel Therapeutics Inc
Eligibility
Inclusion criteria
Inclusion criteria: Subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Healthy male or female subject (with equal percentage for both) aged between 18-40 years, both inclusive. 2. Subject able to understand the investigational nature of this study and give written informed consent prior to study entry. 3. In the opinion of the principal investigator or designee, subject should be sufficiently physically healthy to receive an oral dose of Yohimbine. 4. Subject must be able to comply with study requirements in the opinion of Investigator. 5. Subject with normal physical examination, electrocardiogram and hemodynamic parameters. 6. Women of child-bearing potential must have a negative urine pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
Exclusion criteria
Exclusion criteria: Subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Female subject who is pregnant, breast feeding, or planning a pregnancy. 2. Healthy volunteers after having night shift. 3. Subject with history of hypersensitivity to study drug or any excipient included in the study medications. 4. Subject with any sign and symptoms suggesting of COVID- 19 infection. 5. Subject with any history of illicit substance use and any psychoactive medication for the 4 weeks preceding the test session. 6. Subject with history of significant traumatic brain injury. 7. Subject with focal neurological deficits or any previous history of agitation episode. 8. Subject with clinically significant psychiatric illnesses or unstable medical illnesses. 9. Subject with clinically significant sleep apnea or chronic obstructive pulmonary disease. 10. Subject with increased risk of suicide in the judgment of the principal investigator or designee. 11. Subject with known significant clinical laboratory abnormalities (including positivity for hepatitis B and C, HIV) unless treated to remission status. 12. Subject with drug or alcohol dependence or prolonged abuse within the last 6 months in the opinion of the principal investigator or designee. 13. Subject with presence of any of the following cardiovascular comorbidities: advanced heart block (second-degree or above atrioventricular block without pacemaker), diagnosis of sick sinus syndrome, history of severe ventricular dysfunction (left ventricular ejection fraction 140 mmHg or diastolic BP 14. Subject with moderate/severe renal or hepatic impairment. 15. Subject having treatment with antidiuretics or alpha-1 noradrenergic blockers including any antihypertensive and/or antipsychotic medications (e.g., iloperidone, quetiapine). 16. Subjects having any kind sympathomimetic (pseudoephedrine phenethylamine and amphetamine chemical class) drug in last 48 Hrs. 17. Subjects having any stimulant like nicotine or caffeine (tea, coffee or chewing tobacco, having smoke in morning of dosing). 18. Participated in any other clinical study using experimental drug within past 30 days of prior to baseline visit. 19. Donation of blood within 30 days prior to screening or plasma donation within 7 days prior to screening. 20. Subject who is institutionalized. 21. Other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility of quantifying differences between Yohimbine and Placebo groups using multimodal data from wearable and other devices as a measure of early sympathetic hyperarousal and using IMT test as a measure of impulsivityTimepoint: 16 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To assess the feasibility of developing classifiers based on multimodal data obtained by the wearable and other device data detecting early sympathetic hyperarousal as induced with Yohimbine. â?¢ To determine the sensitivity, specificity, accuracy of the developed classifiers and assess the clinical utility. Timepoint: 16 Days | — |
Countries
India
Contacts
Public ContactMr Prashant Sabane
Cliantha Research Limited
Outcome results
None listed