Pharmacokinetics and Safety of BI 695501

NCT02899338 | Completed Phase 1 Results

• 2 other identifiers: 1297.132016-003158-34
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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 Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI

  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.

  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.

• 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.

  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.

  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.

Secondary Outcomes (1)

• The Percentage of Subjects With Drug-related Treatment-emergent Adverse Events (TEAEs) From Day 1 to Day 70.

  From Day 1 to Day 70

Study Arms (2)

BI695501 Autoinjector

EXPERIMENTAL

Drug: BI695501Autoinjector

BI695501 Prefilled syringe

ACTIVE COMPARATOR

Drug: BI695501 Prefilled syringe

Interventions

BI695501 Prefilled syringe DRUG

BI695501 Prefilled syringe

BI695501Autoinjector DRUG

BI695501 Autoinjector

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years (inclusive)
• BMI of \>17.5 to \<35.0 kg/m2
• Healthy male or female subjects, according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure \[BP\], pulse rate \[PR\]), 12-lead ECG, and clinical laboratory tests.
• Subjects who meet any of the following criteria:
• Surgically sterilized (confirmed 6 month prior to enrollment)
• Have surgically sterilized sexual partner (confirmed 6 month prior to enrollment)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
• Subjects agree to use an adequate contraception, starting from the begin of the trial and until 6 months after the dose of the trial drug: e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
• Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial

You may not qualify if:

• Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.
• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) that deviates from normal and judged as clinically relevant by the investigator.
• Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
• History of relevant orthostatic hypotension, fainting spells, or blackouts.
• Chronic or relevant acute infections.
• Positive result for HIV, hepatitis B virus (HBV), and hepatitis C (Hep C) at screening.
• History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.
• Intake of an investigational drug in another trial within 2 months or 5 half-lives (whichever longer) prior to planned administration of the trial medication in this trial or intake of an investigational drug during the course of this trial.
• Alcohol abuse (consumption of more than 28 units/week).
• Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 14 post trial medication administration; and/or to limit alcohol intake to a maximum of 3 units per day until e.o.t.
• Drug abuse or positive drug screening.
• Blood donation of more than 500 mL within 30 days prior to administration of trial medication or intended donation during the trial.
• Intention to perform excessive physical activities within 4days prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 14 days post dosing.
• Inability to comply with dietary regimen of trial site.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

SGS Life Sciences Services

Antwerp, 2060, Belgium

Location

PRA Health Sciences Onderzoekscentrum Martini

Groningen, 9728 NZ, Netherlands

Location

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: September 21, 2016
• Primary Completion: February 9, 2017
• Study Completion: February 23, 2017
• Last Updated: October 11, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-10

Locations

BE (1); NL (1)