A double-blind, randomized, placebo-controlled, combined single and multiple ascending dose study to investigate the safety, tolerability and pharmacokinetic profile of AB928 in healthy volunteers.

A double-blind, randomized, placebo-controlled, combined single and multiple ascending dose study to investigate the safety, tolerability and pharmacokinetic profile of AB928 in healthy volunteers. - AB928 single and multiple ascending dose study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46373

Enrollment

Registered

2017-10-12

Start date

2017-10-12

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

Kanker Cancer.

Interventions

Part A: Group 1

Day 1

AB928, 10 mg or placebo

once daily Group 2: Day 1

AB928, 25 mg or placebo

once daily Group 3: Day 1

AB928, 75 mg or placebo

once daily Group 4: Day 1

AB928, 150 mg or placebo

once daily Group 5: Day 1

AB928, 100 mg or placebo

every 12 hours Part B: Group 1

Day 1,2,3,4

once daily Group 2: Day 1,2,3,4

once daily Group 3: Day 1,2,3,4

once daily Group 4: Day 1,2,3,4

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers Age 18 - 55 years, inclusive BMI 19 - 30 kilograms/meter2 Non-smokers or ex-smokers who ceased smoking > 3 months prior to screening visit

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 assess the safety and tolerability of AB928 after single and multiple oral doses.	—

Secondary

Measure	Time frame
To assess the potential pharmacodynamic (PD) effects of AB928 To characterize the pharmacokinetic (PK) profile of AB928 after single and multiple oral doses To investigate the effect of food on the PK of AB928 To investigate the bioequivalence (BE) of 2 formulations of AB928 To determine if any QTc prolongation occurs with AB928	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)