Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Olatec Therapeutics, Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age 18 to 60 years old, inclusive
In good health as determined by the Investigator based on subject's medical history, ECG and physical examination at Baseline and safety laboratory tests (chemistry, hematology, coagulation and urinalysis) at Screening
Normal blood pressure of 130/85 mmHg or lower
Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study
You may not be if
Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
1. Are or intend to become pregnant (including use of fertility drugs) during the study
2. Are nursing
3. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic \[injectable or patch\] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the study.)
Use of any drug treatment at the time of the study (with the exception of 81 mg aspirin and prescription oral or systemic contraceptives)
Taking any prescription medications (other than oral or systemic contraceptives) within 14 days prior to administration of investigational drug or taking any over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 14 days prior to administration of investigational drug, except for topical products without systemic absorption
Use of NSAIDs or other prescription pain medication, more than once or twice a week, especially if taken for chronic or frequently recurring headache
Active infection within 3 days of the Baseline visit
History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
Diagnosed with any form of internal cancer within the past 5 years
Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements
History of anaphylactic reactions to any systemic or topical compounds
Have donated plasma (500 mL) within 7 days prior to drug administration
Have donated or lost whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration
Is a user of any nicotine products (including chewing tobacco, snuff and/or e-cigarettes)
Is not willing to restrict food or beverage including: alcohol, caffeine, poppy seeds, xanthine derivatives or xanthine-related compounds, energy drinks, natural health products, grapefruit juice, pomelo, Seville orange and marmalade use during the study as specified in Section 7.1.5
Is lactose intolerant
Is unable or unwilling to consume products containing bovine byproducts
Is unable to adhere to or understand the requirements of the protocol
If continuing on to Part B, subject is unable or unwilling to ingest the full study-provided high-fat breakfast within 30 minutes
Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit
Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01, Study OLT1177-02 or Study OLT1177-03
Clareo Health | Phase 1 Safety and PK Study of OLT1177 Capsules
