A single-center randomized, adaptive, investigator/participant blind, single oral ascending dose, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7189752 in healthy male participants.

A single-center randomized, adaptive, investigator/participant blind, single oral ascending dose, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7189752 in healthy male participants. - Entry-into-Human study of RO7189752

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45777

Enrollment

Registered

2018-07-06

Start date

2018-08-08

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Multiple sclerosis

Interventions

RO7189752 or placebo will be given as a drink of 100 milliliters (mL) in the morning of Day 1 at 30 minutes (approx. 5 minutes) after the start of a standardized breakfast. The breakfast has to be c

a double-blinded study. However, if it is important for volunteers health to know if he has received RO7189752 or placebo, for example in case of a serious side effect, this information can be look

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male subjects -18-45 yrs, inclusive -BMI: 18.0-30.0 kg/m2, inclusive -Non-smoking or light-smoking

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 evaluate the safety and tolerability of single oral ascending doses of RO7189752 in healthy male participants.	—

Secondary

Measure	Time frame
To investigate the PK of RO7189752 in plasma and urine, and if appropriate, its metabolite(s) after single oral doses. To assess the PD of RO7189752 after single oral doses.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)