To evaluate human pharmacokinetics of the drug, paclitaxel in MozecTM PEB for PTA

Mozec PEB PTA PK Study: A prospective, single-arm, multi-centre pharmacokinetic study to evaluate human pharmacokinetics of the drug, paclitaxel in MozecTM PEB for PTA. - N/A

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/059285

Enrollment

Registered

2023-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: I739- Peripheral vascular disease, unspecified

Interventions

Intervention1: Mozec PEB: Mozec PEB consists of a drug (Paclitaxel) coated balloon (dilatation element) near the distal tip and dual lumen shaft. Intervention2: Baloon Angioplasty: The dilation of st

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are planned for treatment with 1-unit MozecTM PEB PTA in real-world settings and is suitable for participation in this pharmacokinetic study at discretion of investigator.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females. 2. Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated. 3. A subject with any other conditions in the opinion of the investigator not recommended for multiple pharmacokinetic blood sample collections (HIV, Hepatitis, etc.) 4. Patients receiving treatment having known pharmacokinetic drug Interaction with paclitaxel.

Design outcomes

Primary

Measure	Time frame
1.Paclitaxel Levels- Measurement of paclitaxel concentration in the circulating blood at baseline / pre-procedure (10 min prior to procedure), immediately after balloon deployment, & then at 10 min (± 2min), 30 min (± 2min), 1 hr (± 5 min), 4 hr (± 5 min), 8 hr (± 5 min), 24 hrs (± 10 min), Day 7 (± 1 day), Day 14 (± 1 day), post-procedure. (Post 1st attempt of balloon inflation)1 (note- From pharmacokinetic point of view, the drug release starts from the 1st attempt of balloon inflation, hence all post procedure time point for PK samples will be considered in reference to the time of 1st attempt of balloon inflation.) 2. Freedom from device & procedure-related death Freedom from device & procedure-related death through 14 days post- procedure. Timepoint: up to 14 days	—

Measure

Time frame

1.Paclitaxel Levels- Measurement of paclitaxel concentration in the circulating blood at baseline / pre-procedure (10 min prior to procedure), immediately after balloon deployment, & then at 10 min (± 2min), 30 min (± 2min), 1 hr (± 5 min), 4 hr (± 5 min), 8 hr (± 5 min), 24 hrs (± 10 min), Day 7 (± 1 day), Day 14 (± 1 day), post-procedure. (Post 1st attempt of balloon inflation)1 (note- From pharmacokinetic point of view, the drug release starts from the 1st attempt of balloon inflation, hence all post procedure time point for PK samples will be considered in reference to the time of 1st attempt of balloon inflation.) 2. Freedom from device & procedure-related death Freedom from device & procedure-related death through 14 days post- procedure. Timepoint: up to 14 days

—

Secondary

Measure	Time frame
Measurements of Pharmacokinetic variables: Cmax, Tmax, AUC [Time Frame: (0- t) & half-life]Timepoint: up to 14 days	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt. Ltd.

ashok.thakkar@merillife.com912603052100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026