Pharmacokinetics and Safety of BI 695501

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI695501Autoinjector; Drug: BI695501 Prefilled syringe

• Registration Number: NCT02899338
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Study Start: 2016-09-21
• Primary Completion: 2017-02-09
• Study Completion: 2017-02-23
• Results First Submitted: 2018-01-31
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-05
• Last Update Submitted: 2018-10-05
• Results First Posted: 2018-10-11
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI695501 Autoinjector	BI695501Autoinjector	-
BI695501 Prefilled syringe	BI695501 Prefilled syringe	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) After Administration Via PFS and AI.	Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.	The AUC0-∞ of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.
The Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI	From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.	The Cmax of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI.	From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.	The AUC0-1368 of 40 mg BI 695501 administered via PFS and AI was measured. Plasma concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA). Only concentration values within the validated concentration range of 0.025 to 2.0 micrograms per millilitre (µg/mL) and actual sampling times were used.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Subjects With Drug-related Treatment-emergent Adverse Events (TEAEs) From Day 1 to Day 70.	From Day 1 to Day 70	A treatment-related TEAE was defined as any TEAE assessed by the Investigator as related to the trial medication. A TEAE was defined as an adverse event (AE) that started or worsened in severity on or after the single dose of trial medication up to 10 weeks (70 days) post-dose.

Trial Locations

Locations (2)

SGS Life Sciences Services; 🇧🇪 Antwerpen, Belgium

PRA Health Sciences Onderzoekscentrum Martini; 🇳🇱 Groningen, Netherlands