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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03229291
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date July 25, 2017
Actual Study Start Date  ICMJE November 3, 2016
Actual Primary Completion Date June 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • Incidence of adverse events (AEs) [ Time Frame: Day 28 ]
    Incidence and severity of AEs events during the treatment and observation periods of the study
  • Incidence of clinical laboratory abnormalities [ Time Frame: Day 28 ]
    Incidence and severity of clinical laboratory measurements that are outside the normal range
  • Change in vital signs: blood pressure [ Time Frame: Baseline and Day 28 ]
    Change from baseline in blood pressure
  • Change in vital signs: temperature [ Time Frame: Baseline and Day 28 ]
    Change from baseline in temperature
  • Change in vital signs: respiratory rate [ Time Frame: Baseline and Day 28 ]
    Change from baseline in respiratory rate
  • Change in vital signs: pulse rate [ Time Frame: Baseline and Day 28 ]
    Change from baseline in pulse rate
  • Change in electrocardiogram (ECG) parameters [ Time Frame: Baseline and Day 28 ]
    Change from baseline in 12-lead ECG parameters
  • Plasma pharmacokinetics (PK): Cmax [ Time Frame: Day 1 ]
    Maximum plasma concentration (Cmax) estimate for SM04755 following first dose
  • Plasma pharmacokinetics (PK):tmax [ Time Frame: Day 1 ]
    Time to Cmax estimate for SM04755 following first dose
  • Plasma pharmacokinetics (PK): AUC [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose
  • Plasma pharmacokinetics (PK):half-life [ Time Frame: Day 1 ]
    Plasma terminal phase half-life estimate for SM04755 following first dose
  • Plasma pharmacokinetics (PK):Cmax [ Time Frame: Day 14 ]
    Maximum plasma concentration (Cmax) estimate for SM04755 following last dose
  • Plasma pharmacokinetics (PK):tmax [ Time Frame: Day 14 ]
    Time to Cmax estimate for SM04755 following last dose
  • Plasma pharmacokinetics (PK): AUC [ Time Frame: Day 14 ]
    AUC estimate for SM04755 following last dose
  • Plasma pharmacokinetics (PK):half-life [ Time Frame: Day 14 ]
    Plasma terminal phase half-life estimate for SM04755 following last dose
  • Change in skin score assessment: erythema [ Time Frame: Baseline and Day 28 ]
    Change from baseline in erythema skin score assessment
  • Change in skin score assessment: scaling [ Time Frame: Baseline and Day 28 ]
    Change from baseline in scaling skin score assessment
  • Change in skin score assessment: pruritus/itching [ Time Frame: Baseline and Day 28 ]
    Change from baseline in pruritus/itching skin score assessment
  • Change in skin score assessment: burning/stinging [ Time Frame: Baseline and Day 28 ]
    Change from baseline in burning/stinging skin score assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
Incidence of AEs relative to exposure [ Time Frame: Day 28 ]
Incidence and severity of AEs relative to measured plasma exposure to SM04755
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
Official Title  ICMJE A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
Brief Summary This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1 (SM04755:placebo).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tendinopathy
Intervention  ICMJE
  • Drug: SM04755
    SM04755 is a small molecule inhibitor of the Wnt pathway.
  • Drug: Vehicle
    Same formulation as topical SM04755 solution, without SM04755 included.
Study Arms  ICMJE
  • Experimental: Low Dose
    Topical SM04755 solution (15 mg/mL) applied once per day for 14 days
    Intervention: Drug: SM04755
  • Experimental: Mid Dose
    Topical SM04755 solution (45 mg/mL) applied once per day for 14 days
    Intervention: Drug: SM04755
  • Experimental: High Dose
    Topical SM04755 solution (90 mg/mL) applied once per day for 14 days
    Intervention: Drug: SM04755
  • Placebo Comparator: Vehicle
    Vehicle solution applied once per day for 14 days
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 11, 2017
Actual Primary Completion Date June 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index of 18 to 30 kg/m^2 at study start
  • Subject must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
  • Willingness to comply with all scheduled study visits, laboratory tests, contraception requirements and other study procedures
  • Appropriate skin characteristics at site of application (inner thigh) (for example, consistent pigmentation, no tattoos, no scarring or noted injury, no varicose veins or structural repair)
  • Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period that includes double barrier, intrauterine device (IUD), or hormonal contraceptive combined with single barrier, or abstinence
  • Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control (e.g., IUD or hormonal contraception combined with single barrier).
  • History of, or current, skin disease (for example, psoriasis, atopic dermatitis, seborrheic dermatitis, and skin cancer)
  • History of, or current, skin damage at the treatment site (inner thigh) (for example, cuts, abrasion, sunburn, sun-damage, or scarring)
  • Phototherapy or use of a tanning salon 2 weeks prior to study start until end of the study (Day 28)
  • History of, or current, allergy to investigational product/placebo ingredients
  • Known allergy to adhesive tape
  • Current evidence of malignancy or history of malignancy within the last 5 years prior to study start; prior history of in situ cancer or basal or squamous cell skin cancer, completely excised, is allowed
  • Treatment with an investigational product within 12 weeks prior to study start; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to study start
  • Use of any prescription or nonprescription drugs [except birth control or hormone replacement therapy (HRT)], topical skin treatments on the application site (inner thigh), vitamins, grapefruit/grapefruit juice, or dietary or herbal supplements within 14 days prior to study start
  • Blood donation of ≥ 1 pint (473 mL) within 56 days prior to study start or unwilling to refrain from blood donation for the duration of the study
  • Plasma or platelet donation within 14 days prior to study start or unwilling to refrain from plasma or platelet donation for the duration of the study
  • Unwilling to refrain from sperm donation for the duration of the study and until 90 days after dose administration
  • Prior or current latent or active tuberculosis (TB) or nontuberculous mycobacteria infection.
  • Evidence of active infection or illness involving fever within 7 days prior to study start
  • Occurrence of serious illness requiring hospitalization within 6 months prior to study start
  • Regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months prior to study start
  • Use of tobacco- or nicotine-containing products (cigarettes, pipe, cigar, chewing tobacco or nicotine gum, lozenges or patches) within 30 days prior to study start
  • A history of abuse of prescription or illicit drugs within 6 months prior to study start
  • Marijuana use within 28 days prior to study start
  • Previous treatment with SM04755
  • Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
  • Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
  • Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229291
Other Study ID Numbers  ICMJE SM04755-TOP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samumed LLC
Study Sponsor  ICMJE Samumed LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yusuf Yazici, M.D. Samumed LLC
PRS Account Samumed LLC
Verification Date July 2017

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