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

NCT06063343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • LINK Medical Research AB

    collaborator UNKNOWN

  • Q&Q Labs AB

    collaborator UNKNOWN

  • CRST Oy

    collaborator INDUSTRY

  • Novakand Pharma AB

    lead INDUSTRY

Principal Investigators

  • Johan Schulz · Novakand Pharma AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2024-04-08
Completion
2024-04-08

Countries

  • Finland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063343 on ClinicalTrials.gov