BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

NCT03212586 | Completed Phase 1

• 2 other identifiers: 189222017-000978-11
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Conditions

Clinical Trials, Phase I as Topic

Outcome Measures

Primary Outcomes (2)

• Number of subjects with treatment-emergent adverse events

  AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.

  Up to 11 weeks

• Number of subjects with severity of treatment-emergent adverse events

  AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).

  Up to 11 weeks

Study Arms (2)

Dose escalation BAY1902607

EXPERIMENTAL

Dose 1 to 9 of BAY1902607

Drug: BAY1902607

Dose escalation Placebo

PLACEBO COMPARATOR

Dose 1 to 9 of matching placebo

Drug: Placebo

Interventions

BAY1902607 DRUG

Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)

Dose escalation BAY1902607

Placebo DRUG

Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)

Dose escalation Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects.
• Age: 18 to 45 years (inclusive) .
• Body mass index (BMI) : ≥18 and ≤30 kg/m\^2.
• Race: White.

You may not qualify if:

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
• Relevant diseases within the 4 weeks before the first drug administration.
• Febrile illness within the week before the first taste test is conducted.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study Design

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

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: July 18, 2017
• Primary Completion: May 3, 2018
• Study Completion: July 27, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

DE (1)