A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Single Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Effect of Food on Pharmacokinetics of CAL-120 in Healthy Male Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Single Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Effect of Food on Pharmacokinetics of CAL-120 in Healthy Male Subjects - CAL-120 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35937

Enrollment

Registered

2011-03-15

Start date

2011-03-28

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

cancer solid tumors

Interventions

Active substance: CAL-120 Activity: PI3-kinase inhibitor Dosage form: capsule Active substance: Ketoconazol Activity: CYP3A4 inhibitor Dosage form: tablet

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male Age between 18 and 65 years, inclusive. BMI between 18 and 30 kg/m2, inclusive. Non smoking or smoking a maximum of 5 cigarettes per day

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 the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Secondary

Measure	Time frame
Pharmacodynamics (by platelet aggregation and basophil activation , as well as the effect of food)	—

Primary

Measure	Time frame
Safety, tolerability Pharmacokinetics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)