Clinical trial NCT01636141: Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects
Official title: A Phase 1, Randomized, Dose Escalation, Single Center, Safety Study of Single and Multi-Dose, Topically Applied OLT1177 Gel in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Pharmacokinetics
Dose escalation
Randomized
Healthy volunteers
Topical
OLT1177
Olatec
Pain
Inflammation
Lead sponsor: Olatec Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 36
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: TREATMENT

Brief summary: The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.

Detailed description: OLT1177 Gel is being developed for the topical treatment of pain and inflammation emanating from musculoskeletal and certain skin inflammatory conditions.

This is a Phase 1 study evaluating the safety and tolerability of OLT1177 Gel in healthy subjects when given as single-dose or multi-dose applications. The study will be conducted in two parts, Part A and Part B. In Part A, approximately 18 healthy subjects in 3 dose escalating cohorts will be randomized to receive a single dose of the investigational drug (5 subjects OLT1177 Gel and 1 subject placebo gel). Upon completion of Part A, a new subject population of approximately 18 subjects in 3 dose escalating cohorts will be randomized in Part B of the study. Subjects will receive a total of 8 doses over 3 consecutive days given 6 hours apart while awake during the day and will be followed for up to 30 days for safety assessment.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women 18 to 60 years of age
* Women of childbearing potential must have a negative urine pregnancy test within 3 days of study enrollment and must agree to use a highly effective form of contraception
* Subjects must be in good health as determined by the Investigator based on medical history, ECG, physical examination and safety laboratory test
* 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:

* Subjects with a known hypersensitivity to the investigational drug
* Subjects who are pregnant or lactating
* Participation in any investigational drug or device study and receipt of any investigational drug or device within the immediate 30 days prior to the start of this study
* Concurrent or recent use of analgesics, steroids, allergy medications, H2 blockers within 48 hours of the start of the study
* Subjects with a prior knee injury or surgery within the last 5 years
* Subjects with an active infection or with a fever ≥ 38°C within 3 days of the start of the study
* Subjects with a history of, or known to be positive for, HIV, hepatitis B or C
* Subjects with uncontrolled hypertension as defined by systolic blood pressure (SBP) \> 150 mm/Hg, diastolic blood pressure (DBP) \> 100 mm/Hg
* Subjects with a wound or skin irritation or any skin condition, e.g., psoriasis in the treatment area
* Subjects who are taking prescription medications with the exception of oral or systemic contraceptives
* Subjects who have systemic diseases
* Subjects who have a history of anaphylactic reactions to any systemic or topical compounds

Primary outcomes:
measure: Recording of adverse events
timeFrame: Part A - during the 7 days following the application of the study drug and Part B during the 14 day following each application of the study drug
Secondary outcomes:
measure: Area under the Concentration curve (AUC)
timeFrame: Part A - Pre-dose, 15 minutes, 30 minutes, 1, 2, 4 and 6 hours post dose and Days 2, 3 and 7. Part B - Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, and 6 hours post dose, Days 2, 3 (15 minutes, 30 minutes, 1, 2, 4 and 6 hours post dose) Days 4, 7 and 14
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
role: PRINCIPAL_INVESTIGATOR
References: