Trial Outcomes & Findings for Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus (NCT NCT02016625)

NCT ID: NCT02016625

Last Updated: 2016-05-23

Results Overview

AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity). PK sampling (relative to the first cyclo administration \[h:min\]) Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h. period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: up to 168 hours (details in description)
• Results posted on: 2016-05-23

Participant Flow

The trial was nonrandomised, open-label and fixed-sequence and was performed in 2 separate groups of 2 periods each in healthy male and female volunteers. Treatments for the two periods were in group 1 cyclosporine (cyclo) and cyclo and faldaprevir (FDV), and in Group 2 tacrolimus (tac) and tac and FDV.

Participant milestones

Measure	Cyclosporine / Cyclosporine + Faldaprevir fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.	Tacrolimus / Tacrolimus + Faldaprevir fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
Cyclo or Tac (Single Dose, Day 1) STARTED	16	16
Cyclo or Tac (Single Dose, Day 1) COMPLETED	16	15
Cyclo or Tac (Single Dose, Day 1) NOT COMPLETED	0	1
Cyclo or Tac (Day 1) + FDV (Day -7 to 7) STARTED	16	15
Cyclo or Tac (Day 1) + FDV (Day -7 to 7) COMPLETED	13	15
Cyclo or Tac (Day 1) + FDV (Day -7 to 7) NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Cyclosporine / Cyclosporine + Faldaprevir fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.	Tacrolimus / Tacrolimus + Faldaprevir fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
Cyclo or Tac (Single Dose, Day 1) not treated	0	1
Cyclo or Tac (Day 1) + FDV (Day -7 to 7) Adverse Event	1	0
Cyclo or Tac (Day 1) + FDV (Day -7 to 7) not specified above	2	0

Baseline Characteristics

Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus

Baseline characteristics by cohort

Measure	Cyclosporine / Cyclosporine + Faldaprevir n=16 Participants fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.	Tacrolimus / Tacrolimus + Faldaprevir n=15 Participants fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.	Total n=31 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	41.5 years STANDARD_DEVIATION 8.8 • n=7 Participants	41.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.

AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity).

PK sampling (relative to the first cyclo administration [h:min])

Period 1:

for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h.

period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

Outcome measures

Measure	Cyclosporine n=16 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=13 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)	672 ng*h/mL Geometric Coefficient of Variation 17.4	732 ng*h/mL Geometric Coefficient of Variation 25.1

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS cyclo

AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point).

PK sampling (relative to the first cyclo administration [h:min]):

Period 1:

for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

Outcome measures

Measure	Cyclosporine n=16 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=13 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)	635 ng*h/mL Geometric Coefficient of Variation 16.2	685 ng*h/mL Geometric Coefficient of Variation 25.2

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS cyclo

Cmax (maximum measured concentration of the cyclo in plasma).

PK sampling (relative to the first cyclo administration [h:min]):

Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=16 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=13 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
Cmax (Maximum Measured Concentration of the Cyclo in Plasma)	172 ng/mL Geometric Coefficient of Variation 34.7	164 ng/mL Geometric Coefficient of Variation 27.8

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.

Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval τ).

PK sampling (relative to the first cyclo administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=14 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)	1740 ng/mL Geometric Coefficient of Variation 225	2470 ng/mL Geometric Coefficient of Variation 331

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.

PK sampling (relative to the first cyclo administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=14 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)	619 ng/mL Geometric Coefficient of Variation 194	723 ng/mL Geometric Coefficient of Variation 205

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.

AUC τ,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval τ).

PK sampling (relative to the first cyclo administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=14 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)	24600 ng*h/mL Geometric Coefficient of Variation 196	30600 ng*h/mL Geometric Coefficient of Variation 267

PRIMARY outcome

Timeframe: up to 192 hours (details in description)

Population: pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.

AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity).

PK sampling (relative to the first tac administration):

Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac

-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)	16.0 ng*h/mL Geometric Coefficient of Variation 57.6	20.4 ng*h/mL Geometric Coefficient of Variation 62.9

PRIMARY outcome

Timeframe: up to 192 hours (details in description)

Population: PKS tac

AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point).

PK sampling (relative to the first tac administration [h:min]):

Period 1: for tac

0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h

Period 2 For tac

-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)	11.1 ng*h/mL Geometric Coefficient of Variation 62.8	15.3 ng*h/mL Geometric Coefficient of Variation 66.2

PRIMARY outcome

Timeframe: up to 192 hours (details in description)

Population: PKS tac

Cmax (maximum measured concentration of the tac in plasma).

PK sampling (relative to the first tac administration [h:min]):

Period 1:

for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac

-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
Cmax (Maximum Measured Concentration of the Tac in Plasma)	1.14 ng/mL Geometric Coefficient of Variation 35.5	1.13 ng/mL Geometric Coefficient of Variation 48.9

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS tac

Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).

PK sampling (relative to the first tac administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)	3120 ng/mL Geometric Coefficient of Variation 35.7	2930 ng/mL Geometric Coefficient of Variation 51.3

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS tac

PK sampling (relative to the first tac administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)	904 ng/mL Geometric Coefficient of Variation 56.1	900 ng/mL Geometric Coefficient of Variation 52.1

PRIMARY outcome

Timeframe: up to 168 hours (details in description)

Population: PKS tac

AUC τ,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).

PK sampling (relative to the first cyclo administration [h:min]):

period 2 For FDV

-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h.

Outcome measures

Measure	Cyclosporine n=15 Participants fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.	Cyclosporine + Faldaprevir n=15 Participants fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)	40300 ng*h/mL Geometric Coefficient of Variation 39.1	38700 ng*h/mL Geometric Coefficient of Variation 48.3

Adverse Events

Cyclosporine (Cyclo)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Tacrolimus (Tac)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

FDV (ff Cyclo)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

FDV (ff Tac)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Cyclo+FDV

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Tac+FDV

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cyclosporine (Cyclo) n=16 participants at risk Cyclosporine (cyclo) 50 mg	Tacrolimus (Tac) n=15 participants at risk Tacrolimus (tac) 0.5 mg	FDV (ff Cyclo) n=15 participants at risk FDV 120 mg (followed by cyclosporine)	FDV (ff Tac) n=15 participants at risk FDV 120 mg (followed by tacrolimus)	Cyclo+FDV n=14 participants at risk Cyclosporine 50 mg + FDV 120 mg	Tac+FDV n=15 participants at risk Tacrolimus 0.5 mg + FDV 120 mg
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.

Other adverse events

Measure	Cyclosporine (Cyclo) n=16 participants at risk Cyclosporine (cyclo) 50 mg	Tacrolimus (Tac) n=15 participants at risk Tacrolimus (tac) 0.5 mg	FDV (ff Cyclo) n=15 participants at risk FDV 120 mg (followed by cyclosporine)	FDV (ff Tac) n=15 participants at risk FDV 120 mg (followed by tacrolimus)	Cyclo+FDV n=14 participants at risk Cyclosporine 50 mg + FDV 120 mg	Tac+FDV n=15 participants at risk Tacrolimus 0.5 mg + FDV 120 mg
Blood and lymphatic system disorders Anaemia	6.2% 1/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Ear and labyrinth disorders Vertigo	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	7.1% 1/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Eye disorders Ocular icterus	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	13.3% 2/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Eye disorders Eye pruritus	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Eye disorders Photophobia	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	14.3% 2/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Dry mouth	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	20.0% 3/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Nausea	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	20.0% 3/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	20.0% 3/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Flatulence	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	14.3% 2/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Vomiting	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	7.1% 1/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Dyspepsia	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
General disorders Fatigue	6.2% 1/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	7.1% 1/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
General disorders Feeling hot	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
General disorders Pyrexia	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Infections and infestations Rash pustular	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Injury, poisoning and procedural complications Incorrect dose administered	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Metabolism and nutrition disorders Decreased appetite	6.2% 1/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Musculoskeletal and connective tissue disorders Sensation of heaviness	6.2% 1/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Nervous system disorders Headache	31.2% 5/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	20.0% 3/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	20.0% 3/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	26.7% 4/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Nervous system disorders Dizziness	6.2% 1/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Nervous system disorders Burning sensation	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Nervous system disorders Paraesthesia	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Psychiatric disorders Sleep disorder	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/16 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	6.7% 1/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/14 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.	0.00% 0/15 • from the date of start trial medication to 28 days after the last trial medication. Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER