Multiple Ascending Dose Putative Cognitive Enhancer VU319

Inclusion Criteria

• •1. Men and women aged 18 through 55 years, inclusive.
• •2. Body mass index 18 through 32 kg/m2
• •3. Determined as healthy based on screening medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG without clinically significant abnormalities. QTc interval with Fridericia's correction method recorded on screening and predose must be less than 450 msec for male and less than 470 in females.
• •4. Clinical laboratory test result without clinically significant abnormalities at screening and at admission.
• •5. Negative tests for Hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody at screening.
• •6. Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 6 months and do not use any drug for smoking cessation).
• •7. Negative screen for drugs of abuse at screening and admission.
• •8. Negative screen for alcohol at admission.
• •9. For Women: Must have no child-bearing potential by reason of a sterilization procedure or at least 1 year post-menopausal (i.e. 12 months without menstrual period), or menopause confirmed with follicle-stimulating hormone level of \> 30 IU/L at screening.
• •10. For Men: Must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of child-bearing potential or must agree to use an effective method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository) through the study and for 28 days after last dose of study drug.
• •11. Able and willing to be available for the duration of the study.
• •12. Willing and able to give written informed consent to participate.
• •13. Able to understand and comply with protocol instructions.
• •14. Agrees not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge.
• •15. Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to admission and through 7 days after final discharge. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.
• •16. Agrees not to use nicotine-containing products from screening through 48 hours after discharge.
• •17. Agrees not to consume alcohol for the 72 hours prior to admission and through 48 hours after discharge.
• •18. Agrees not to eat grapefruit or drink grapefruit juice within 7 days prior to admission and through 24 hours after discharge.
• •19. Agrees to not drink caffeinated drinks from 72 hours prior to admission through discharge.
• •20. Agrees not to eat or drink (except water) for 8 hours before and 4 hour after dosing for all MAD cohort subjects.