Age and Gender Effects on the Pharmacokinetics of BAY85-3934

NCT01458028 | Completed Phase 1

• 1 other identifier: 14631
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.

Conditions

Anemia

Keywords

BAY85-3934; pharmacokinetics; age; gender

Outcome Measures

Primary Outcomes (6)

• Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934

  Measured over 72 hours after dosing

• Maximum drug concentration in plasma after single dose administration of BAY85-3934

  Measured over 72 hours after dosing

• Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)

  Measured over 96 hours after dosing

• Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event)

  Measured over 96 hours after dosing

• Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline)

  Measured over 72 hours after dosing

• Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)

  Measured over 48 hours after dosing

Secondary Outcomes (5)

• Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours

  48 hours post dose

• Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours

  96 hours post dose

• Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours

  48 hours post dose

• Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours

  96 hours post dose

• Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours

  96 hours post dose

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: BAY85-3934

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BAY85-3934 DRUG

Single doses of 20 mg BAY85-3934 as tablet

Arm 1

Placebo DRUG

Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No diagnosis of any specific disease or condition
• Subjects are expected to be in good general health for their respective age range
• Male or female gender
• Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
• Racial group: Caucasian

You may not qualify if:

• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
• Clinically relevant findings in the physical examination

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Anemia; Coitus

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Sexual Behavior; Behavior

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 24, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)