A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors

Sponsor
Health Hope Pharma
Study ID
NCT07580833
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral Paclitaxel in combination with Encequidar tablet — DRUG
    Participant is either fasted or fed when taking Oral Paclitaxel in combination with Encequidar tablet

Study Details

The goal of this clinical trial is to learn about the effect of food on absorption of oral Paclitaxel when co- administered with Encequidar tablets in adult patients with tumours. The main questions it aims to answer are: * The effect of food and fasting on absorption of oral paclitaxel when combined with Encequidar tablets * Assessment of safety and tolerability of oral paclitaxel when combined with Encequidar tablets Participants will take Encequidar and oral paclitaxcel with a 1-hour space in between, either after an overnight fast of 10hours or after a meal three days in a row. After 10 days participants that received paclitaxel after fasting will receive the same medicine in the same way after a meal and vice versa. Some participants can elect to take part in the third part of the study which involves taking both paclitaxel and encequidar at the same time after a meal. Participants will \- For parts 1,2 and 3 participants will stay at the clinic from the day before the study starts until day 4 to receive the medicine and participate in checkups and tests. Participants will then visit the clinic on day 6 and 8 for further checkups and tests

Key Dates

First listed
May 12, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: The Effect of Food on the Bioavailability of Oral Paclitaxel Administered with Encequidar
    The Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal.
  • Experimental: The Effect of Fasting on the Bioavailability of Oral Paclitaxel Administered with Encequidar
    The Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal.

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-t) and AUC from time 0 to infinity (AUC0-INF) of oral paclitaxel when paclitaxel is administered one hour following encequidar. [ Time Frame: Plasma sample collected from pre-dose on Day 1 to Day 8. ]

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