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)

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 425809

Study type: Interventional

Funder types: Industry

Identifiers

NCT02337283

2014-004390-16 (EudraCT Number)

1346.2

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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
• Further exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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96 participants in 7 patient groups, including a placebo group

BI 425809 very low dose - part I

Experimental group

Description:

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

Treatment:

Drug: BI 425809

Placebo - part I

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

BI 425809 low dose - part I

Experimental group

Description:

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

Treatment:

Drug: BI 425809

BI 425809 medium dose - part I

Experimental group

Description:

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

Treatment:

Drug: BI 425809

BI 425809 high dose -part I

Experimental group

Description:

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

Treatment:

Drug: BI 425809

BI 425809 low dose - part II

Experimental group

Description:

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

Treatment:

Drug: BI 425809

BI 425809 very high dose -part I

Experimental group

Description:

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

Treatment:

Drug: BI 425809