Trial Outcomes & Findings for Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment (NCT NCT01580306)

NCT ID: NCT01580306

Last Updated: 2015-07-31

Results Overview

area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity. In this endpoint, the data of AUC0-∞ show inter-individual variabilities.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
• Results posted on: 2015-07-31

Participant Flow

Participant milestones

Measure	Normal Renal Function Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2
Overall Study STARTED	8	8	8	8
Overall Study COMPLETED	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

Baseline characteristics by cohort

Measure	Normal Renal Function n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2	Total n=32 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 2.1 • n=5 Participants	58.8 years STANDARD_DEVIATION 9.3 • n=7 Participants	67.1 years STANDARD_DEVIATION 7.5 • n=5 Participants	57.6 years STANDARD_DEVIATION 9.5 • n=4 Participants	61.4 years STANDARD_DEVIATION 8.2 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration

Population: Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.

area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.

In this endpoint, the data of AUC0-∞ show inter-individual variabilities.

Outcome measures

Measure	Normal Renal Function n=5 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment n=4 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment n=7 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2
AUC0-∞	76500 ng*h/mL Geometric Coefficient of Variation 95.7	86900 ng*h/mL Geometric Coefficient of Variation 89.8	136000 ng*h/mL Geometric Coefficient of Variation 67.2	129000 ng*h/mL Geometric Coefficient of Variation 98.8

PRIMARY outcome

Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration

Population: PK set

maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.

Outcome measures

Measure	Normal Renal Function n=5 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment n=4 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment n=7 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2
Cmax	3810 ng/mL Geometric Coefficient of Variation 80.7	4080 ng/mL Geometric Coefficient of Variation 144.0	6680 ng/mL Geometric Coefficient of Variation 63.2	4600 ng/mL Geometric Coefficient of Variation 135.0

SECONDARY outcome

Timeframe: from drug administration up to 2 weeks

Population: treated set

Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Outcome measures

Measure	Normal Renal Function n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG Blood bilirubin increased	0 participants	0 participants	0 participants	1 participants
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG blood pressure systolic increased	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: drug administration until end-of-study examination (7 to 14 days after drug administration)

Population: treated set

number of participants with investigator-defined drug related adverse events.

Outcome measures

Measure	Normal Renal Function n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate \>= 90 mL/min/1.73m2	Mild Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2	Moderate Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2	Severe Renal Impairment n=8 Participants Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2
Number of Participants With Drug Related Adverse Events	5 participants	8 participants	5 participants	7 participants

Adverse Events

BI 201335 Relevant Treatment Dose (Normal Renal Function)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

BI 201335 Relevant Treatment Dose (Mild Renal Impairment)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

BI 201335 Relevant Treatment Dose (Severe Renal Impairment)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BI 201335 Relevant Treatment Dose (Normal Renal Function) n=8 participants at risk Capsule for oral administration estimated glomerular filtration rate \>= 90 mL/min/1.73m2	BI 201335 Relevant Treatment Dose (Mild Renal Impairment) n=8 participants at risk Capsule for oral administration estimated glomerular filtration rate 60-89 mL/min/1.73m2	BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) n=8 participants at risk Capsule for oral administration estimated glomerular filtration rate 30-59 mL/min/1.73m2	BI 201335 Relevant Treatment Dose (Severe Renal Impairment) n=8 participants at risk Capsule for oral administration estimated glomerular filtration rate 15-29 mL/min/1.73m2
Gastrointestinal disorders Diarrhoea	37.5% 3/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	75.0% 6/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	62.5% 5/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	87.5% 7/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Gastrointestinal disorders Nausea	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	37.5% 3/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	25.0% 2/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Gastrointestinal disorders Vomiting	37.5% 3/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	50.0% 4/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Investigations Blood bilirubin increased	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Investigations Blood pressure systolic increased	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Nervous system disorders Headache	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Nervous system disorders Syncope	12.5% 1/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.	0.00% 0/8 • From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing) Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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