A single-center, open-label, two sequence, crossover study to investigate the interaction between Colistin Methansulfonate Sodium (CMS) and RO7033877 in healthy subjects.

A single-center, open-label, two sequence, crossover study to investigate the interaction between Colistin Methansulfonate Sodium (CMS) and RO7033877 in healthy subjects. - RO7033877/Colistin Methanesulfonate Sodium (CMS) DDI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41756

Enrollment

Registered

2014-06-13

Start date

2014-07-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

pneumonia serious infections

Interventions

The study will consist of 3 periods during which the volunteer will receive multiple doses of RO7033877 alone (Period 1 or 2), multiple doses of CMS alone (Period 1 or 2), and multiple doses of RO70

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18 - 55 years of age, inclusive BMI 18.0 - 30.0 kilograms/meter2 Weight 60 kg or more, but less than 100 kg no smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To investigate the potential pharmacokinetic (PK) drug-drug interaction between RO7033877 and colistin methanesulfonate sodium (CMS) in healthy subjects.	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of RO7033877 administered alone or in combination with CMS in healthy subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)