Clinical trial NCT02134964: Phase 1 Safety and PK Study of OLT1177 Capsules
Official title: A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Pharmacokinetics
Dose escalation
Randomized
Healthy volunteers
OLT1177
Olatec
Lead sponsor: Olatec Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recording of adverse events
timeFrame: Screening through Day 28 follow-up
Secondary outcomes:
measure: Safety Laboratory Measurements
timeFrame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
measure: Electrocardiogram
timeFrame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
measure: Vital Signs
timeFrame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
measure: Physical Examination
timeFrame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Other outcomes:
Locations:
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
Study officials:
affiliation: J&S Studies
name: Terry M Jones, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: