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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000767-88 | EudraCT Number | EudraCT |
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To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or delayed type, to UV light and visible light in healthy male and female subjects. To investigate the degree, wavelength dependency, severity, pigmentation and morphology of the phototoxic effects. The persistence of the phototoxic susceptibility will be explored following cessation of study medication. Within a sunscreen sub-study, the efficacy of commercially available high factor sunscreen will also be assessed in terms of its potential to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faldaprevir QD high dose | Experimental | capsules, oral administration with 240 ml water, fed conditions |
|
| Faldaprevir QD low dose | Experimental | tablets/capsules, oral administration with 240 ml water, fed conditions |
|
| Placebo | Placebo Comparator | capsules, oral administration with 240 ml water, fed conditions |
|
| Ciprofloxacin | Active Comparator | tablets, oral administration with 240 ml water, fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faldaprevir high dose | Drug | capsules, oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with drug related adverse events | 17 days | |
| Change in minimum erythema dose (MED) at each wavelength tested, before and during treatment. The change will be quantified by the phototoxic index at 24 hrs (delayed erythema) derived by dividing the baseline MED by that during treatment | 7 days | |
| Percentage of subjects with drug related adverse events | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of phototoxic effects by phototoxic index | 7 days |
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Inclusion criteria:
Exclusion criteria:
- Any relevant deviation from healthy conditions.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.42.44001 Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
capsule, oral |
|
| Ciprofloxacin | Drug | tablets, oral |
|
| Faldaprevir low dose | Drug | capsules, oral |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |