Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olatec Industries LLC
ClinicalTrials.gov Identifier:
NCT01636141
First received: July 5, 2012
Last updated: September 5, 2012
Last verified: September 2012

July 5, 2012
September 5, 2012
June 2012
August 2012   (final data collection date for primary outcome measure)
Recording of adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

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.

To determine the safety and tolerability of OLT1177 Gel when administered to healthy subjects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01636141 on ClinicalTrials.gov Archive Site
Area under the Concentration curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects
A Phase 1, Randomized, Dose Escalation, Single Center, Safety Study of Single and Multi-Dose, Topically Applied OLT1177 Gel in Healthy Subjects

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: OLT1177 Gel
    OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
  • Drug: Placebo gel
    none
  • Placebo Comparator: Placebo gel
    Each study group consists of 6 subjects randomized in a 5:1 ratio to receive OLT1177 Gel or placebo gel in both Part A and B of the study. Eighteen subjects will be enrolled in Part A and 18 in Part B. A total of 30 subjects will receive OLT1177 Gel and 6 subjects will receive placebo gel.
    Intervention: Drug: Placebo gel
  • Active Comparator: OLT1177 Gel
    Each study group consists of 6 subjects randomized in a 5:1 ratio to receive OLT1177 Gel or placebo gel in both Part A and B of the study. Eighteen subjects will be enrolled in Part A and 18 in Part B. A total of 30 subjects will receive OLT1177 Gel and 6 subjects will receive placebo gel.
    Intervention: Drug: OLT1177 Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01636141
OLT1177-01
No
Olatec Industries LLC
Olatec Industries LLC
Not Provided
Principal Investigator: Terry M Jones, MD J&S Studies
Olatec Industries LLC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP