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Ovarian CancerPhase 1NCT06063343

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

A Phase 1 study testing KAND145 in people with Ovarian Cancer, run by Novakand Pharma AB at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer
What is being tested?
KAND145
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteFinland
Study dates
9 Nov 2023to 8 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of written informed consent prior to any other study specific procedures.
  • Body weight >50 kg.
  • BMI ≥19.0 and <30.0 kg/m^2 at screening.
  • Healthy male and female subjects aged >18 and <65 years at screening.
  • Male subjects must agree to use an adequate method of contraception; Male subjects who are heterosexually active must use a condom with their partner, from the time of IMP administration until 72 hours after dosing of IMP, AND from the time of IMP administration until 90 days after dosing of IMP at least one of the following highly effective contraception methods (as per the Clinical Trial Facilitation Group, guidelines, 21/09/2020 Version 1.1) must be used by their female sexual partner:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
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  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion or hysterectomy
  • Vasectomized male Or if the male subject has a post-menopausal partner.
  • Female subjects must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months' amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone 25-140 IU/L and estradiol <200 pmol/L is confirmatory]).
  • Female subjects of childbearing potential may be included if it is their preferred and permanent lifestyle to abstain from heterosexual relationships, and if they agree to continue such abstinence and to avoid starting of a pregnancy during their study participation.
  • Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.

Who cannot join

  • Present or known history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental, metabolic, endocrine, hematologic, or gastrointestinal disorder, significant respiratory disease, sleep apnea, narcolepsy or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator.
  • Any clinically significant abnormalities in physical examination, ECG (e.g., QTcF>450 ms for males/>460 ms for females), clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator.
  • Clinically significant abnormal blood pressure, defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 90 mmHg at screening.
  • Pulse rate <45 beats per minute at screening.
  • Clinically significant illness within the 5 days prior to the administration of the IMP.
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus.
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  • Known or suspected current or history of (within the most recent 5 years) drug or alcohol abuse or positive screen for drugs of abuse test or positive alcohol breath test at screening visit or any time prior to randomization.
  • Smoking >5 cigarettes per day (or equivalent consumption of other nicotine-containing products), or inability to refrain from smoking or using other nicotine-containing products during the stay at the study clinic.
  • Subject who has received any investigational drug within the last 3 months before administration of IMP, or who has received any dose of KAND567 in a previous clinical study.
  • Plasma donation within 1 month of the screening visit, or any blood donation/blood loss >450 mL during the 3 months prior to the screening visit.
  • Use of the herbal remedy St. John's Wort during 2 weeks prior to administration of the IMP (induces cytochrome P450-3A4).
  • Use of prescribed medication during 2 weeks prior to the administration of the IMP (or longer if the prescribed medication has a half-life long enough to potentially expose the subject to any significant systemic exposure, as judged by the Investigator).
  • Use of over the counter drugs (including herbals) during 1 week prior to the administration of the IMP or need for concomitant medications during the study. However, use of the following may be allowed: occasional paracetamol for pain relief (up to 3 g per 24 hours), vitamin D (up to 20 μg per 24 hours), supplementation therapy with thyroxin, iron, calcium, folate, estrogen, vitamin B12, and other vitamins and minerals at recommended doses, as judged by the Investigator. Intake of preparations containing iron, calcium or other metal ions will not, however, be permitted in the 10 hours preceding and 4 hours following IMP intake. Thus, their use cannot be allowed during the treatment period of Part 2.
  • Female subjects: Positive pregnancy test at screening visit or at any time prior to dosing.
  • Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Clinical Research Services Turku - CRST Oy

    Turku, 20520

Other trials in Finland

About this study

Official title: 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

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.

Read the 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
Being tested
KAND145, Placebo
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KAND145Drug

    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.

  • PlaceboDrug

    Participants randomized to the placebo arms will receive placebo at the same dosing frequency as the experimental arms.

Study groups in NCT06063343
Study groupRoleWhat they receive
KAND145 for SAD (Part 1)ExperimentalIn Part 1, SAD of KAND145 will be administered to up to 6 cohorts. Six participants in each cohort will receive KAND145. The first cohort will receive a starting dose of 60 mg KAND145 which is expected to lead to an average drug plasma concentration (Cave) of 0.2 µM. The maximum dose will be chosen to achieve a Cave of 10 µM.
Receives: Drug: KAND145
Placebo for SAD (Part 1)Placebo comparatorIn Part 1, 2 participants per cohort in up to 6 cohorts will receive placebo at the same dosing frequency as detailed for the experimental arm.
Receives: Drug: Placebo
KAND145 for MAD (Part 2)ExperimentalIn Part 2, MAD of KAND145 will be administered to up to 5 cohorts. Six participants in each cohort will receive doses of KAND145 BID for 8 days. The first cohort will receive a dose of KAND145 which is expected to lead to a Cave of 2 µM. The maximum daily dose will be 3000 mg KAND145.
Receives: Drug: KAND145
Placebo for MAD (Part 2)Placebo comparatorIn Part 2, 2 participants per cohort in up to 5 cohorts will receive placebo at the same dosing frequency as detailed for the experimental arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Safety - Adverse events

    Frequency and severity of AEs will be determined.

    Measured: From dosing (Day 1) until last follow-up (10-14 days post-dosing)

  2. Part 1: Safety - Vital signs

    Measured by the occurrence of clinically abnormal vital signs. Unit of measure: percent change from baseline

    Measured: From dosing (Day 1) until last follow-up (10-14 days post-dosing)

  3. Part 1: Safety - electrocardiogram (ECG)

    Measured by the occurrence of clinically abnormal ECG. Unit of measure: percent change from baseline

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  4. Part 1: Safety - Safety laboratory tests

    Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology and urinalysis). Unit of measure: percent change from baseline.

    Measured: From screening until last follow-up (10-14 days after dosing)

  5. Part 2: PK - Maximum plasma (peak) drug concentration (Cmax)

    Assessed for KAND145 and KAND567(AM) during steady state.

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  6. Part 2: PK - Time to reach Cmax following drug administration (tmax)

    Assessed for KAND145 and KAND567(AM) during steady state.

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  7. Part 2: PK - Area under plasma concentration-time curve AUCτ

    Assessed for KAND145 and KAND567(AM) during steady state

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  8. Part 2: PK - Average plasma drug concentration (Cave [AUCτ/12])

    Assessed for KAND145 and KAND567(AM) during steady state

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  9. Part 2: PK - Terminal half-life (t½z)

    Assessed for KAND145 and KAND567(AM) during steady state.

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

Secondary outcomes (13)

  1. Part 1 - PK: Cmax

    Assessed for KAND145 and KAND567(AM) after single doses.

    Measured: From Day 1 until 24 hours post-dose

  2. Part 1 - PK: tmax

    Assessed for KAND145 and KAND567(AM) after single doses.

    Measured: From Day 1 until 24 hours post-dose

  3. Part 1 - PK: AUCinf

    Assessed for KAND145 and KAND567(AM) after single doses.

    Measured: From Day 1 until 24 hours post-dose

  4. Part 1 - PK: Cave (AUCinf/12 h)

    Assessed for KAND145 and KAND567(AM) after single doses.

    Measured: From pre-dose (within 60 minutes) until 24 hours post-dose

  5. Part 1 - PK: t1/2z

    Assessed for KAND145 and KAND567(AM) after single doses.

    Measured: From Day 1 until 24 hours post-dose

  6. Part 2 - Safety: AEs

    Frequency and severity of AEs will be determined

    Measured: From the day before the first dose (Day -1) until last follow-up (10-14 days after the last dose)

  7. Part 2 - Safety: Vital signs

    Measured by occurrence of clinically abnormal vital signs. Unit of measure: percent change from baseline

    Measured: From the day before the first dose (Day -1) until Day 8

  8. Part 2 - Safety: ECG

    Measured by the occurrence of clinically abnormal ECG. Unit of measure: percent change from baseline

    Measured: From Day -1 until Day 8

  9. Part 2: Safety - Safety laboratory tests

    Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology and urinalysis). Unit of measure: percent change from baseline

    Measured: From Day -1 until last follow-up (10-14 days after the last dose)

  10. Part 2 - PK: Cmax for midazolam

    Only applicable for participants in Cohort 2:1 and Cohort 2:2 that will participate in the midazolam-part of the study.

    Measured: From Day 1 until Day 9 of the midazolam-part of the study

  11. Part 2 - PK: tmax for midazolam

    Only applicable for participants in Cohort 2:1 and Cohort 2:2 that will participate in the midazolam-part of the study.

    Measured: From Day 1 until Day 9 of the midazolam-part of the study

  12. Part 2 - PK: AUCinf for midazolam

    Only applicable for participants in Cohort 2:1 and Cohort 2:2 that will participate in the midazolam-part of the study.

    Measured: From Day 1 until Day 9 of the midazolam-part of the study

  13. Part 2 - PK: t½z for midazolam

    Only applicable for participants in Cohort 2:1 and Cohort 2:2 that will participate in the midazolam-part of the study.

    Measured: From Day 1 until Day 9 of the midazolam-part of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start9 Nov 2023
  3. Primary completion8 Apr 2024
  4. Study completion8 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1 - SAD: Up to 48 participants will be sequentially enrolled into up to 6 cohorts (8 participants per cohort). The first 2 participants in all cohorts will be randomized to KAND145 or placebo in a 1:1 ratio. The 6 remaining participants will be randomized to KAND145/placebo in a 5:1 ratio. FE-part: After a wash-out period of 6-14 days after dosing with KAND145/placebo, Cohort 1:3 will receive a second dose of KAND145/placebo (as per initial randomization) together with a meal. Part 2 - MAD: Up to 40 participants will be sequentially enrolled into up to 5 cohorts (8 participants per cohort). Participants in each cohort will be randomly assigned to KAND145 or placebo in a 3:1 ratio. Midazolam-part: Two cohorts will receive a single dose of 4 mg midazolam. After a wash-out period of 6-14 days, the participants will start dosing of KAND145/placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063343
Sponsor's protocol ID
KAN0008
Other IDs
2023-503909-11-01, 2023
Status last verified
Apr 2024
First submitted
17 May 2023
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KAND145 in people with Ovarian Cancer, run by Novakand Pharma AB at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Safety - Adverse events (time frame: From dosing (Day 1) until last follow-up (10-14 days post-dosing)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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