Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects

NCT01318551 | Completed Phase 1

• 2 other identifiers: 155572011-000055-16
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.

Conditions

Anemia

Keywords

Anemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Up to 4 weeks

Secondary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC) of BAY85-3934

  Day 0 to day 4

• Peak Plasma Concentration (Cmax) of BAY85-3934

  Day 0 to day 4

• Dose-normalized area under the plasma concentration-time curve (AUCnorm) of BAY85-3934

  Day 0 to day 4

• Dose- and body weight-normalised Cmax (Cmax-norm) of BAY85-3934

  Day 0 to day 4

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: BAY85-3934

Arm 2

EXPERIMENTAL

Drug: BAY85-3934

Arm 3

EXPERIMENTAL

Drug: BAY85-3934

Interventions

BAY85-3934 DRUG

single dose, 20 mg

Arm 1

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The informed consent must be signed before any study-specific tests or procedures are done.
• Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations \>30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
• Male subjects who agree to use 2 forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
• Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
• Age: ≥18 and ≤79 years at the pre-study visit.
• Body mass index (BMI): ≥18 and ≤34 kg/m2.
• Ethnicity: white.
• Subjects participating in this trial and having received 20 mg BAY 85 3934 are encouraged to participate in the following optionally 40 mg and 80 mg study parts.
• Ability to understand and follow study-related instructions.
• For subjects with renal impairment:
• In diseased subjects: CLCR \<90 mL/min determined from a serum creatinine control.
• In diseased subjects: stable renal disease, ie a serum creatinine value determined at least 3 months before the pre-study visit during routine diagnostics independently of the study should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
• For healthy subjects:
• Mean age and body weight in Group 1 or Group 6 or Group 11 (control group, healthy subjects) and Groups 2 to 5 and Groups 7 to 10 and Groups 12 to 15 should not vary by more than +10 years and +10 kg, respectively..
• In diseased subjects: CLCR ≥90 mL/min determined from a serum creatinine control.

You may not qualify if:

• Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).
• Donation of \>100 mL of blood within 4 weeks before the first study drug administration or \>500 mL in the preceding 3 months.
• Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
• Severe infection or any clinically significant illness within 4 weeks prior to dosing.
• Known hypersensitivity to the study drugs (active substances, or excipients of the preparations).
• Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
• Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus antibodies (HIV 1/2 Ab).
• Regular use of recreational drugs, eg carnitine products, anabolics.
• Regular daily consumption of ≥ 0.5 L of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form.
• Suspicion of drug or alcohol abuse.
• Positive urine drug screening.
• Regular daily consumption of \>25 cigarettes.
• Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
• Use of medication within the 2 weeks preceding the study which could interfere with the investigational product.
• For subjects with renal impairment:

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 18, 2011
• Study Start: March 16, 2011
• Primary Completion: September 5, 2013
• Study Completion: August 14, 2014
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

DE (1)