Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis
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|ClinicalTrials.gov Identifier: NCT02337205|
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: KX2-391 Ointment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Single-Center, Safety, Tolerability, and Pharmacokinetic Study of KX2 391 Ointment in Subjects With Actinic Keratosis|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
|Experimental: KX2-391 Ointment||
Drug: KX2-391 Ointment
KX2-391 Ointment will be applied at a predetermined concentration to the treatment area for a predetermined time period.
- Overall safety and tolerability assessment as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information. [ Time Frame: 45 days ]Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine analytes; periodic measurement of vital signs and ECGs; and the performance of physical examinations as detailed in Table 3 of the protocol.
- The amount of KX2-391 in the blood stream as determined by pharmacokinetic (PK) analysis: Cmax, Cmin, AUC0-t, AUC0-inf [ Time Frame: 7 days ]Individual PK data will be listed by time. Cmax, Cmin, AUC0-t, AUC0-inf will be calculated for KX2-391 to determine systemic exposure.
- Actinic Keratosis (AK) lesion count [ Time Frame: 45 days ]The AK lesion count is the investigator's assessment of the number of AK lesions in the treatment area.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337205
|United States, Texas|
|Austin, Texas, United States, 78759|
|Study Director:||Douglas Kramer, MD||Kinex Pharmaceuticals|