A phase 1, randomized, placebo-controlled study to assess the safety and pharmacokinetics of multiple ascending dose regimens of TP-6076.

A phase 1, randomized, placebo-controlled study to assess the safety and pharmacokinetics of multiple ascending dose regimens of TP-6076. - TP-6076 MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45496

Enrollment

Registered

2017-10-15

Start date

2017-03-29

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Infecties. Infections.

Interventions

Group 1

Day 1 to 7 TP-6076 6.0 mg or placebo

once daily Group 2

Day 1 to 7 TP-6076 20.0 mg or placebo

once daily Group 3

Day 1 to 7 TP-6076 40.0 mg or placebo

once daily Group 4

Day 1 to 7 TP-6076 60.0 mg or placebo

once daily Group 5

Day 1 TP-6076 40.0 mg or placebo

twice daily Treatment for Group 6 and 7 will be decided based on the results from previous groups. You will be informed about the amount and frequency of the study compound administration after you

Infections with bacteria for which other antibiotics dont work anymore.

TP-6076

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male or female 18-55 years, inclusive BMI 18.0-35.0 kilogram/meter2 Weight between 50 (female) and 60 (male) and 105 kilograms, inclusive Non smokers

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 multiple dose regimens of TP-6076.	—

Secondary

Measure	Time frame
To determine the plasma pharmacokinetic (PK) profile for TP-6076, its carbon-4 (C-4) epimer TP-5589, and degradation products TP-2847 and TP-5031 following multiple doses. To determine the urinary excretion of TP-6076 following multiple doses.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)