A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND THE EFFECT OF FOOD AND KETOCONAZOLE ON THE PHARMACOKINETICS OF IPI-145 WHEN ADMINISTERED TO HEALTHY ADULT SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND THE EFFECT OF FOOD AND KETOCONAZOLE ON THE PHARMACOKINETICS OF IPI-145 WHEN ADMINISTERED TO HEALTHY ADULT SUBJECTS - IPI-145 SAD/MAD/FE/DDI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35436

Enrollment

106

Registered

2011-07-19

Start date

2011-07-26

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

blood malignancies inflammatory diseases

Interventions

Active substance: IPI-145 or placebo In Part 2: 2 times DTH (subcutaneus injection of anti-bodies) with tetanus, candida, trichopython and tuberculin.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 18 * 55 years, inclusive BMI: 18.0 * 30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, C, 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 within 60 days from the start of the study or in case of donating more than 1.5 liter (for men)/ 1.0 liter (for women) of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics Pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)