NCT06063343

Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145

A First-in-human, Single-center, Placebo-controlled, Randomized, Double-blind Study in Healthy Subjects to Evaluate Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam After Oral Single and Multiple Ascending Dosing of KAND145

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novakand Pharma AB · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to learn more about the study candidate drug, KAND145, when given to healthy volunteers. The study will consist of two parts. In Part 1, the goal is to find out if the study drug KAND145 is safe and tolerable after a single dose. First, a small group of participants will receive a liquid for swallowing containing a low dose of the study drug or a liquid for swallowing that does not contain any drug. If this is safe and tolerable, higher doses will be given to subsequent groups of participants. Additionally, the effect of food on the metabolism of the study drug will be studied. In Part 2, the goal is to find out how the body absorbs, distributes, and gets rid of the study drug when it is taken twice a day for 8 days. As in Part 1, first a liquid for swallowing containing a low dose of the study drug or a liquid for swallowing that does not contain any study drug will be given to a first group of participants; additional doses will then be given to subsequent groups of participants. Additionally, it will be studied if the study drug KAND145 affects the pharmacokinetics of the medicine midazolam.

Detailed description

This is a Phase 1, first-in-human (FIH), single-center, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, PK, food effect (FE) and interaction with midazolam after oral single ascending dosing (SAD; Part 1 of the study) and multiple ascending dosing (MAD; Part 2 of the study) of KAND145. A Safety Review Committee (SRC) will evaluate safety data from each dose cohort before proceeding with the subsequent cohort. The study population will consist of healthy adult male and female volunteers. Up to 88 participants (up to 48 participants in Part 1, up to 40 participants in Part 2) are planned to be enrolled in the study, at one investigational site. Part 1: In this part, participants receive single doses of KAND145 or placebo. Four ascending dose levels (cohorts) are planned; this may be extended with up to 2 optional dosing cohorts. In one cohort, a potential food interaction will be studied in the FE-part. Part 2: In this part, participants receive KAND145 or placebo twice a day (BID) for 8 consecutive days. Two ascending dose levels (cohorts) are planned; this may be extended with up to 3 optional dose levels (cohorts). To find out whether KAND145 has an effect on CYP3A4-mediated drug metabolism, the interaction of KAND145/placebo with midazolam will be studied in two cohorts.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	KAND145	In Part 1 of the study, single ascending doses of KAND145 will be administered; in Part 2 of the study, multiple ascending doses (BID for 8 days) of KAND145 will be administered.
DRUG	Placebo	Participants randomized to the placebo arms will receive placebo at the same dosing frequency as the experimental arms.

Timeline

• Start date: 2023-11-09
• Primary completion: 2024-04-08
• Completion: 2024-04-08
• First posted: 2023-10-02
• Last updated: 2024-04-22

Locations

1 site across 1 country: Finland