First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

July 22, 2016

Primary Completion Date

May 11, 2017

Study Completion Date

August 23, 2017

Conditions
Clinical Trials, Phase I as Topic
Interventions
DRUG

BAY1817080

Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])

DRUG

Placebo

Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food \[Continental breakfast\])

DRUG

Itraconazole

Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Trial Locations (1)

13353

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY