TKL Research, Inc. Site Number : 8400001
Fair Lawn, New Jersey, 07410, United States
NCT Number: NCT05844735
This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age.
There will be two parts:
* Part I is a randomized placebo-controlled trial comparing sensitivity to ultraviolet (UV) light in participants treated with SAR441566 to those treated with placebo. * Part II is an open label arm consisting of participants treated with ciprofloxacin which induces mild phototoxicity and serves as a positive control.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Fair Lawn, New Jersey, 07410, United States
The overall duration of the study for each participant will be up to approximately 48 days
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Tablet
Tablet
Tablet
Time frame: On-drug Day 8
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation.
Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) [290 to 400 nm] exposure.
Time frame: On-drug Day 8
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation.
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time frame: On-drug Day 9
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation.
Condition 1 is a Full range solar UVB/UVA [290 to 400 nm] exposure.
Time frame: On-drug Day 8
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation.
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: On-drug Day 8
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation.
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: On-drug Day 9
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation.
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: Baseline (Day -2 to Day -1) and on-drug (Day 8 to Day 9)
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure and condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: At Baseline (Day -2 to Day 1 pre-dose) and on-drug (Day 8 to Day 11)
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure, condition 2 is a UVA only [320 to 400 nm] exposure and condition 3 is a full solar range UVB/UVA + UVA [16 J/cm2] exposure.
Time frame: Day 8 to Day 11
Maximum plasma concentration observed
Time frame: Day 8 to Day 11
Time to reach Cmax
Time frame: Day 8 to Day 9
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (0 to 24 hours)
Time frame: Up to Day 20
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including serious adverse event (SAE) and adverse event of special interests (AESI)
Time frame: On-drug Day 8
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time frame: On-drug Day 8
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time frame: On-drug Day 9
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time frame: On-drug Day 8
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: On-drug Day 8
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time frame: On-drug Day 9
Condition 2 is a UVA only [320 to 400 nm] exposure.
Sanofi
Industry
A Two-part, Randomized Partially-blinded, Parallelgroup, Placebo- and Active Comparatorcontrolled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03649178
Arthritis, Arthritis, Rheumatoid
Nashville, Tennessee, United States
View Trial DetailsNCT03025308
Arthritis, Arthritis, Rheumatoid
Huntsville, Alabama, United States
View Trial DetailsNCT07715045
Arthritis, Arthritis, Rheumatoid
Palembang, South Sumatera, Indonesia
View Trial DetailsNCT00055055
Arthritis, Arthritis, Rheumatoid
Bethesda, Maryland, United States
View Trial Details