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

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trials, Phase I as Topic

Treatments: Drug: Itraconazole; Drug: Placebo; Drug: BAY1817080

Study type: Interventional

Funder types: Industry

Identifiers

NCT02817100

18183

2016-000253-12 (EudraCT Number)

Details and patient eligibility

About

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects
• Age: 18 to 45 years (inclusive)
• Body mass index (BMI) : ≥18 and ≤30 kg/m²
• Race: White

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Relevant diseases within the last 4 weeks prior to the first drug administration
• Existing chronic diseases requiring medication
• Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
• Incompletely cured 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
• Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

BAY1817080

Experimental group

Description:

Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; 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: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])

Treatment:

Drug: BAY1817080

Drug: Itraconazole

Placebo

Placebo Comparator group

Description:

Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080

Treatment:

Drug: Itraconazole

Drug: Placebo