DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES AND THE EFFECT OF FOOD ON ORAL WCK 4873 IN HEALTHY ADULT VOLUNTEERS

DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES AND THE EFFECT OF FOOD ON ORAL WCK 4873 IN HEALTHY ADULT VOLUNTEERS - WCK 4873 Phase 1 SAD FE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38693

Enrollment

Registered

2013-03-06

Start date

2013-03-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Pneumonia Respiratory Tract Infections

Interventions

Single dose of WCK 4873 in the form of tablets up to a maximum of 1200 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18 - 65 years inclusive BMI 18.0 - 30.0 kg/m2 inclusive non-smoker

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in another drug study within 60 days prior to randomization. Any donation of blood(products) or significant blood loss within 60 days prior to drug administration

Design outcomes

Primary

Measure	Time frame
PK Safety Tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)