A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS - FLX475 SAD, MAD and FE Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44307

Enrollment

104

Registered

2017-11-06

Start date

2017-11-17

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

Cancer Treatment

Interventions

n.a.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male or female subjects - 18-55 yrs, inclusive - BMI: 18.0-30.0 kg/m2, inclusive - non-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
Part A: To evaluate the safety and tolerability of single oral ascending doses of FLX475 administered to healthy male and female subjects Part B: To evaluate safety and tolerability of multiple oral ascending doses of FLX475 administered for 14 days to healthy male and female subjects	—

Secondary

Measure	Time frame
Part A: - To evaluate the pharmacokinetics (PK) of FLX475 following administration of single oral ascending doses of FLX475 administered to healthy male and female subjects - To assess the food effect (FE) on the PK of FLX475 following administration of a single oral dose of FLX475 administered to healthy male and female subjects - To compare the PK of an alternative drug product formulation of FLX475 following administration of a single oral dose administered to healthy male and female subjects Part B: - To evaluate the PK of FLX475 following administration of multiple oral ascending doses of FLX475 administered to healthy male and female subjects	—

Measure

Time frame

Part A: - To evaluate the pharmacokinetics (PK) of FLX475 following administration of single oral ascending doses of FLX475 administered to healthy male and female subjects - To assess the food effect (FE) on the PK of FLX475 following administration of a single oral dose of FLX475 administered to healthy male and female subjects - To compare the PK of an alternative drug product formulation of FLX475 following administration of a single oral dose administered to healthy male and female subjects Part B: - To evaluate the PK of FLX475 following administration of multiple oral ascending doses of FLX475 administered to healthy male and female subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)