NDLI: The DGAT1 inhibitor pradigastat does not induce photosensitivity in healthy human subjects: a randomized controlled trial using three defined sunlight exposure conditions

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The DGAT1 inhibitor pradigastat does not induce photosensitivity in healthy human subjects: a randomized controlled trial using three defined sunlight exposure conditions

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The DGAT1 inhibitor pradigastat does not induce photosensitivity in healthy human subjects: a randomized controlled trial using three defined sunlight exposure conditions

Content Provider	Royal Society of Chemistry (RSC)
Author	Noe, Adele Chen, Jin Chen, Yuming Soon, Rachel L. Kulmatycki, Kenneth Bauer, Daniel Meyers, Dan Dosik, Jonathan S.
Copyright Year	2016
Abstract	The DGAT1 inhibitor, pradigastat, demonstrated a mild phototoxicity signal in preclinical studies. Therefore, this clinical trial was conducted to assess the risk of photosensitivity in humans. 47 healthy adults were randomized to part A (double-blind, placebo-controlled; 3 : 1 pradigastat : placebo) or part B (open-label positive control ciprofloxacin, investigator blind). Three irradiation conditions (1. full range UVB/UVA, 2. UVA only, 3. 1/2 MED from UVB/UVA + 16 J cm−2 UVA) were applied to simulate different sunlight exposure conditions. Photosensitizing potential was assessed by determining the minimum erythemal dose (MED) and calculating the photosensitivity index (PI) at 1 and 24 h. Local skin reactions were recorded as a secondary endpoint. Following full UVB/UVA irradiation, there were no significant differences in MED or PI between groups. With UVA-only, no changes in MED or PI were observed for the pradigastat or placebo groups. For ciprofloxacin, there was a significant reduction in MED at 24 h (−32%, vs. 24 h baseline), which correlated to a PI of 1.61. The difference in mean PI between ciprofloxacin–pradigastat, and ciprofloxacin–placebo, was significant at 24 h (p < 0.001). Local skin erythema scores were comparable between pradigastat and placebo, but higher with ciprofloxacin. Pradigastat was not shown to induce photosensitivity reactions, while significant responses were seen with the positive control. These results strongly suggest that pradigastat will not induce photosensitivity reactions in individuals administered doses up to 40 mg per day, which is the highest intended clinical dose. Furthermore, the design of this clinical trial may serve as a prototype for future regulatory clinical photosensitivity studies.
Starting Page	1155
Ending Page	1162
Page Count	8
File Format	HTM / HTML PDF
ISSN	1474905X
Volume Number	15
Issue Number	9
Journal	Photochemical & Photobiological Sciences
DOI	10.1039/c6pp00042h
Language	English
Publisher	Royal Society of Chemistry
Access Restriction	Open
Subject Keyword	UVA DGAT1 Placebo Enzyme inhibitor Phototoxicity Clinical trial Photodermatitis Ciprofloxacin Ultraviolet Erythema
Content Type	Text
Resource Type	Article
Subject	Physical and Theoretical Chemistry

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