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

NCT01636141 | Completed Phase 1

• 1 other identifier: OLT1177-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Safety; Tolerability; Pharmacokinetics; Dose escalation; Randomized; Healthy volunteers; Topical; OLT1177; Olatec; Pain; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Placebo gel

PLACEBO COMPARATOR

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.

Drug: Placebo gel

OLT1177 Gel

ACTIVE COMPARATOR

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.

Drug: OLT1177 Gel

Interventions

OLT1177 Gel DRUG

OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee

OLT1177 Gel

Placebo gel DRUG

Placebo gel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olatec Therapeutics LLC: lead

Study Sites (1)

J&S Studies, Inc

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Terry M Jones, MD

  J&S Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

US (1)