Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 409306

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505894

2011-002369-39 (EudraCT Number)

1289.2

Details and patient eligibility

About

The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.

The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers

Enrollment: 83 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Age >21 and Age <50 years for young healthy volunteers or Age >65 and Age <80 years for elderly healthy volunteers
3. BMI >18.5 and BMI <29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
5. For female subjects: Female subjects must be surgically sterilized or postmenopausal. Surgical sterilization or hysterectomy must have occurred at least 6 months prior to screening. Menopausal women must have no regular menstrual bleeding for at least 2 years prior to screening.

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
6. History or evidence of relevant orthostatic reaction (drop in systolic blood pressure (SBP) >20 mm Hg and increase in heart rate > 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of any drugs within 14 days or drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
12. Smoker (> 5 cigarettes or > 1 cigars or > 1 pipes/day)
13. Inability to refrain from smoking on trial days
14. Alcohol abuse (more than 20 g/day)
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator
19. Inability to comply with dietary regimen of trial site
20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval >430 ms in males and >450 ms in females);
21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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83 participants in 9 patient groups, including a placebo group

Placebo - Young Subjects

Placebo Comparator group

Description:

Placebo - Young Subjects

Treatment:

Drug: Placebo

Placebo - Elderly Subjects

Placebo Comparator group

Description:

Placebo - Elderly Subjects

Treatment:

Drug: Placebo

BI 409306 25 mg - Young Subjects QD

Experimental group

Description:

25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD).

Treatment:

Drug: BI 409306

BI 409306 25 mg - Elderly Subjects QD

Experimental group

Description:

25 mg of BI 409306 were administered in elderly subjects once daily (QD).

Treatment:

Drug: BI 409306

BI 409306 50 mg - Young Subjects QD

Experimental group

Description:

50 mg of BI 409306 were administered in young subjects once daily (QD).

Treatment:

Drug: BI 409306

BI 409306 50 mg - Young Subjects BID

Experimental group

Description:

50 mg of BI 409306 were administered in young subjects twice daily (BID).

Treatment:

Drug: BI 409306

BI 409306 50 mg - Elderly Subjects QD

Experimental group

Description:

50 mg of BI 409306 were administered in elderly subjects once daily

Treatment:

Drug: BI 409306

BI 409306 100 mg - Young Subjects QD

Experimental group

Description:

100 mg of BI 409306 were administered in young subjects once daily (QD).

Treatment:

Drug: BI 409306

BI 409306 100 mg - Elderly Subjects QD

Experimental group

Description:

100 mg of BI 409306 were administered in elderly subjects once daily (QD).

Treatment:

Drug: BI 409306