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Completed

NCT Number: NCT01611311

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1289.17.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male/female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

BI 409306

Drug

Film-coated tablet

Placebo

Drug

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Primary outcomes

  1. Percentage of Subjects With Investigator Defined Drug-Related Adverse Events

    Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days

    Percentage of subjects with investigator defined drug-related Adverse Events (AEs).

  2. Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests

    Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days

    Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.

Secondary outcomes

  1. Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)

    Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

    Maximum measured concentration of the BI 409306 in plasma (Cmax).

  2. Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)

    Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

    Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).

  3. Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)

    Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

    Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24).

  4. Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

    Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

    Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).

  5. Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)

    Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

    Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).

  6. Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)

    Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

    Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Young and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2012
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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