EVALUATION OF SAFETY, TOLERABILITY AND PHARMACOKINETIC CHARACTERISTICS OF MULTIPLE-ASCENDING DOSES OF CG400549 IN HEALTHY VOLUNTEERS

EVALUATION OF SAFETY, TOLERABILITY AND PHARMACOKINETIC CHARACTERISTICS OF MULTIPLE-ASCENDING DOSES OF CG400549 IN HEALTHY VOLUNTEERS - CG400549 Multiple ascending dose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34490

Enrollment

Registered

2010-04-28

Start date

2010-05-11

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

MRSA

Interventions

Active medication Active substance: CG400549 Activity: enoyl-acyl-carrier-protein reductase (Fabl) inhibitor Indication: methicillin-resistant Staphylococcus aureus Strength: 160mg Dosage form: oral c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Sex: male Age: 18-55 years, inclusive BMI: 19-30 kg/m2 No relevant deviations at screening

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor (50 mL or more) within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months preceding the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma and urine CG400549 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination,	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)