Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Dose Escalation, Single Center, Safety Study of Single and Multi-Dose, Topically Applied OLT1177 Gel in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636141
• Other study ID #: OLT1177-01
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2012
• Last updated: September 5, 2012
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Olatec Industries LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• OLT1177 Gel
OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
• Placebo gel

Locations

Country	Name	City	State
United States	J&S Studies, Inc	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Olatec Industries LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of adverse events	Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.; Local skin irritation will be assessed at each visit based on individual signs and symptoms of skin tolerability for erythema, pruritus, scaling/dryness, edema and stinging/burning.	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	Yes
Secondary	Area under the Concentration curve (AUC)		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	Yes