Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

NCT ID: NCT02337283

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-11-30

Brief Summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 425809 very low dose - part I

Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

Placebo - part I

Part I only - placebo tablet, oral administration with 240ml water, over 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets

BI 425809 low dose - part I

Part I - low dose tablet, oral administration with 240 ml water, over 14 days

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

BI 425809 medium dose - part I

Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

BI 425809 high dose -part I

Part I only - high dose tablet, oral administration with 240 ml water, over 14 days

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

BI 425809 low dose - part II

Part II - one low dose tablet on day 1 of visit 2 and 2a

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

BI 425809 very high dose -part I

Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days

Group Type: EXPERIMENTAL

BI 425809

Intervention Type: DRUG

Tablets

Interventions

BI 425809

Tablets

Intervention Type: DRUG

Placebo

Tablets

Intervention Type: DRUG

Other Intervention Names

Iclepertin

Eligibility Criteria

Inclusion Criteria

• 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 electrocardiogram (ECG), and clinical laboratory tests
• age of 18 to 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
• Female subjects who meet any of the following criteria:

1. Surgically sterilised

2. 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)

Exclusion Criteria

• Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg in young subjects, and systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 95 mmHg in elderly subjects, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1346.2.1 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Countries

Germany

References

Moschetti V, Schlecker C, Wind S, Goetz S, Schmitt H, Schultz A, Liesenfeld KH, Wunderlich G, Desch M. Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics. Clin Drug Investig. 2018 Aug;38(8):737-750. doi: 10.1007/s40261-018-0660-2.

Reference Type: DERIVED

PMID: 29846887 (View on PubMed)

Other Identifiers

2014-004390-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1346.2

Identifier Type: -

Identifier Source: org_study_id