Trial Outcomes & Findings for Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers (NCT NCT01605461)

NCT ID: NCT01605461

Last Updated: 2016-03-21

Results Overview

Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
• Results posted on: 2016-03-21

Participant Flow

Participant milestones

Measure	All Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	All Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers

Baseline characteristics by cohort

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Age, Continuous	29.1 Years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration

Population: Pharmacokinetic analysis set (PK set) which 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.

Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
AUC0-infinity of Plasma Deleobuvir	19300 nmol*h/L Geometric Coefficient of Variation 56.5

PRIMARY outcome

Timeframe: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration

Population: PK set

Maximum measured concentration (Cmax) of plasma deleobuvir

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Cmax of Plasma Deleobuvir	3620 nmol/L Geometric Coefficient of Variation 54.2

PRIMARY outcome

Timeframe: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration

Population: PK set

Terminal half life (T1/2) of [14C]-radioactivity in plasma

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
t1/2 of [14C]-Radioactivity in Plasma	2.89 hours Geometric Coefficient of Variation 36.4

PRIMARY outcome

Timeframe: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration

Population: PK set

Excretion balance of total [14C]-radioactivity (urine and faeces)

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Excretion Balance of Total [14C]-Radioactivity	95.2 Percentage of radioactive dose recovered Geometric Coefficient of Variation 1.29

PRIMARY outcome

Timeframe: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration

Population: PK set

Excretion of total [14C]-radioactivity in urine

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Excretion of Total [14C]-Radioactivity in Urine	0.137 Percentage of radioactive dose recovered Geometric Coefficient of Variation 37.8

PRIMARY outcome

Timeframe: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration

Population: PK set

Excretion of total [14C]-radioactivity in faeces

Outcome measures

Measure	All Participants n=12 Participants Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Excretion of Total [14C]-Radioactivity in Faeces	95.1 Percentage of radioactive dose recovered Geometric Coefficient of Variation 1.29

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=12 participants at risk Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Gastrointestinal disorders Nausea	25.0% 3/12 • From drug administration until end of study examination, up to 14 days
General disorders Vessel puncture site haemorrhage	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Injury, poisoning and procedural complications Scratch	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Injury, poisoning and procedural complications Sunburn	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Nervous system disorders Dizziness	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Nervous system disorders Headache	8.3% 1/12 • From drug administration until end of study examination, up to 14 days
Respiratory, thoracic and mediastinal disorders Throat irritation	8.3% 1/12 • From drug administration until end of study examination, up to 14 days

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