Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

December 31, 2013

Conditions
Anemia
Interventions
DRUG

BAY85-3934

Subjects received an oral single dose of placebo tablet matched to the molidustat dose (BAY85-3934) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).

DRUG

BAY85-3934

Subjects received an oral single dose of 5 mg of molidustat IR tablet on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).

DRUG

BAY85-3934

Subjects received an oral single dose of 10 mg of molidustat ( 2x 5mg IR tablets) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).

DRUG

BAY85-3934

Subjects received an oral single dose of 25 mg of molidustat (1 x 20 mg IR tablet and 1 x 5 mg IR tablet) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).

DRUG

BAY85-3934

Subjects received an oral single dose of 50 mg) of molidustat (2 x 20 mg IR tablets and 2 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).

DRUG

BAY85-3934

Subjects received an oral single dose of 75 mg of molidustat (3 x 20 mg IR tablets and 3 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).

Trial Locations (11)

10117

Berlin

13125

Berlin

20253

Hamburg

24105

Kiel

30159

Hanover

30625

Hanover

40225

Düsseldorf

42283

Wuppertal

50931

Cologne

81241

München

SE5 9RS

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01332942 - Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease) | Biotech Hunter | Biotech Hunter