Trial Outcomes & Findings for Pharmacokinetics of Faldaprevir of Soft Capsule (NCT NCT01821937)

NCT ID: NCT01821937

Last Updated: 2015-08-03

Results Overview

C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir

Results posted on

2015-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Faldaprevir 240 mg Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 120 mg Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Overall Study STARTED	15	10
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Faldaprevir 240 mg Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 120 mg Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Overall Study Adverse Event	3	0

Baseline Characteristics

Pharmacokinetics of Faldaprevir of Soft Capsule

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Faldaprevir 240 mg n=15 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Total n=25 Participants Total of all reporting groups	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Age, Continuous	24.8 years STANDARD_DEVIATION 5.7 • n=7 Participants	25.0 years STANDARD_DEVIATION 5.2 • n=5 Participants	25.3 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=7 Participants	13 Participants n=5 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=7 Participants	12 Participants n=5 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir

Population: Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .

C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=11 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Cmax,ss (After Multiple Dosing)	3270 ng/mL Geometric Coefficient of Variation 44.0	14200 ng/mL Geometric Coefficient of Variation 35.5

PRIMARY outcome

Timeframe: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir

Population: Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .

AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=11 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
AUC(Tau,ss) (After Multiple Dosing)	36200 ng*h/mL Geometric Coefficient of Variation 48.5	199000 ng*h/mL Geometric Coefficient of Variation 49.5

SECONDARY outcome

Timeframe: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir

Cmax is defined as maximum measured concentration of Faldaprevir in plasma.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=13 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Cmax (After Single Dosing)	664 ng/mL Geometric Coefficient of Variation 48.7	2060 ng/mL Geometric Coefficient of Variation 44.3

SECONDARY outcome

Timeframe: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir

AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=13 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
AUC(0-tz) (After Single Dosing)	14600 ng*h/mL Geometric Coefficient of Variation 38.9	37900 ng*h/mL Geometric Coefficient of Variation 45.5

SECONDARY outcome

Timeframe: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir

t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=11 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
t(1/2,ss) (After Multiple Dosing)	31.2 hour Geometric Coefficient of Variation 9.27	20.0 hour Geometric Coefficient of Variation 23.6

SECONDARY outcome

Timeframe: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir

tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg n=10 Participants Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg n=11 Participants Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Tmax,ss (After Multiple Dosing)	2.85 hour Geometric Coefficient of Variation 33.6	2.44 hour Geometric Coefficient of Variation 29.8

Adverse Events

Faldaprevir 120 mg Single Dose

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Faldaprevir 120 mg Multiple Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Faldaprevir 240 mg Single Dose

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Faldaprevir 240 mg Multiple Dose

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Faldaprevir 120 mg Single Dose n=10 participants at risk Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.	Faldaprevir 120 mg Multiple Dose n=10 participants at risk Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule. The study was divided into two phases, the first being a single dose and the second a multiple dose. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.	Faldaprevir 240 mg Single Dose n=15 participants at risk Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule The study was divided into two phases, the first being a single dose and the second a multiple dose. During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.	Faldaprevir 240 mg Multiple Dose n=13 participants at risk Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule The study was divided into two phases, the first being a single dose and the second a multiple dose. During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.
Gastrointestinal disorders Abdominal discomfort	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	15.4% 2/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	15.4% 2/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	30.8% 4/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Dyspepsia	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	33.3% 5/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	61.5% 8/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Epigastric discomfort	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Faeces discoloured	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Nausea	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	20.0% 3/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	23.1% 3/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Gastrointestinal disorders Vomiting	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	13.3% 2/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	15.4% 2/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
General disorders Pyrexia	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	23.1% 3/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Alanine aminotransferase abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Alanine aminotransferase increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Aspartate aminotransferase increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Bile output abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Bile output increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Bilirubin conjugated abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	50.0% 5/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	46.2% 6/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Bilirubin conjugated increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	30.0% 3/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	61.5% 8/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood bilirubin abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	60.0% 6/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	53.8% 7/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood bilirubin increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	30.0% 3/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	53.8% 7/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood bilirubin unconjugated increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	80.0% 8/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	92.3% 12/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood cholesterol abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood cholesterol increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood creatine phosphokinase abnormal	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood glucose increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood lactate dehydrogenase abnormal	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood lactate dehydrogenase increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	15.4% 2/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood potassium abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood triglycerides abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	13.3% 2/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Blood triglycerides increased	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Haemoglobin decreased	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Haptoglobin abnormal	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Haptoglobin decreased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Lipase abnormal	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Lipase increased	20.0% 2/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Protein total abnormal	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Protein urine present	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	7.7% 1/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Total bile acids increased	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	10.0% 1/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	6.7% 1/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	15.4% 2/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Urine bilirubin increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	23.1% 3/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)
Investigations Urobilinogen urine increased	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/10 • From first intake of the trial medication until the end of the trial (Up to Day 16)	0.00% 0/15 • From first intake of the trial medication until the end of the trial (Up to Day 16)	23.1% 3/13 • From first intake of the trial medication until the end of the trial (Up to Day 16)