HealthyPhase 1NCT04908800

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects

A Phase 1 study testing KRP-A218 and itraconazole in people with Healthy, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in United Kingdom.

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

This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with itraconazole will be evaluated. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: KRP-A218 and itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteUnited Kingdom
Study dates: 27 May 2021to 21 Apr 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female adults, between 20 and 55 years of age, inclusive.
Body weight ≥50 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
In good health, at Screening or Day -1 as assessed by the Investigator.
Females will not be pregnant or lactating, and females of childbearing potential will agree to use contraception and to not donate eggs (ova, oocytes). Males will agree to use contraception and to not donate sperm.
Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Who cannot join

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.
Use or intend to use any prescription medications/products within 14 days or 5 half-lives (whichever is longer) prior to dosing, unless deemed acceptable by the Investigator.
Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator.
Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to dosing, unless deemed acceptable by the Investigator.

Show all 16Show fewer

Use of tobacco or nicotine-containing products within 3 months prior to Day -1, or positive cotinine test at screening or Day -1.
Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to Day -1.
Consumption of caffeine- or xanthine-containing foods and beverages within 36 hours prior to Day -1.
Participation in strenuous exercised within 7 days prior to Day -1.
Receipt of blood products within 2 months prior to Day -1.
Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
Poor peripheral venous access.
Have previously completed or withdrawn from this study or have previously received the investigational medicinal product (IMP).
Subject is, in the opinion of the Investigator, unlikely to comply with the protocol or unsuitable to participate in this study for any reason.
Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Labcorp Clinical Research
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A First-in-Human, Phase I, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects, Including Food-Effect and Drug-drug Interaction With Itraconazole

Conditions: Healthy
Being tested: KRP-A218, Placebo, itraconazole

What participants receive

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

KRP-A218Drug
KRP-A218 tablet
PlaceboDrug
Placebo tablet
itraconazoleDrug
Also called Sporanox
10 mg/mL oral solution

Study groups in NCT04908800
Study group	Role	What they receive
Part A single ascending dose (SAD) and Part B multiple ascending dose (MAD): KRP-A218	Experimental	Administration Route: Oral Receives: Drug: KRP-A218
Part A (SAD) and Part B (MAD): Placebo	Placebo comparator	Administration Route: Oral Receives: Drug: Placebo
Part C drug-drug interaction (DDI): KRP-A218 and itraconazole	Experimental	Administration Route: Oral Receives: Drug: KRP-A218; Drug: itraconazole

What is being measured

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

Part A: Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose.
Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Measured: Screening to follow-up (Approximately 6 weeks)
Part B: Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose.
Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Measured: Screening to follow-up (Approximately 8 weeks)
Part C: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
The area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity) following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
The area under concentration-time curve from time 0 extrapolated to last quantifiable concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Maximum Observed Concentration (Cmax)
The maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Time of the Maximum Observed Concentration (Tmax)
The time of the maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Apparent Terminal Elimination Half-life (t1/2)
The apparent terminal elimination half-life following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Apparent Total Clearance (CL/F)
The apparent total clearance following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11
Part C: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
The apparent volume of distribution during the terminal phase following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Measured: Days 1 to 11

Secondary outcomes (19)

Part A: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
Area under concentration-time curve from time 0 extrapolated to infinity following single oral dose of KRP-A218
Measured: Day 1
Part A: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Area under curve from time 0 to the time of the last quantifiable concentration following single oral dose of KRP-A218
Measured: Day 1
Part A: Maximum Observed Concentration (Cmax)
Maximum observed concentration following single oral dose of KRP-A218
Measured: Day 1
Part A: Time of the Maximum Observed Concentration (Tmax)
Time of the maximum observed concentration following single oral dose of KRP-A218
Measured: Day 1
Part A: Apparent Terminal Elimination Half-life (t1/2)
Apparent terminal elimination half-life following single oral dose of KRP-A218
Measured: Day 1
Part A: Apparent Total Clearance (CL/F)
Apparent total clearance following single oral dose of KRP-A218
Measured: Day 1
Part A: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase following single oral dose of KRP-A218
Measured: Day 1
Part B: Area Under the Concentration-time Curve Over a Dosing Interval (AUC0-τ)
Assessment of the area under the concentration-time curve over a dosing interval (AUC0-τ)
Measured: Days 1 and 14
Part B: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
Assessment of the area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity)
Measured: Day 1
Part B: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Assessment of the area under curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
Measured: Days 1 and 14
Part B: Maximum Observed Concentration (Cmax)
Assessment of the maximum observed concentration (Cmax)
Measured: Days 1 and 14
Part B: Minimum Observed Concentration (Cmin)
Assessment of the minimum observed concentration (Cmin)
Measured: Day 14
Part B: Time of the Maximum Observed Concentration (Tmax)
Assessment of the time of the maximum observed concentration (Tmax)
Measured: Days 1 and 14
Part B: Apparent Terminal Elimination Half-life (t1/2)
Assessment of the apparent terminal elimination half-life (t1/2)
Measured: Days 1 and 14
Part B: Apparent Total Clearance (CL/F)
Assessment of the apparent total clearance (CL/F)
Measured: Days 1 and 14
Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Assessment of the apparent volume of distribution during the terminal phase (Vz/F)
Measured: Days 1 and 14
Part B: Observed Accumulation Ratio Based on Area Under the Concentration-Time Curve Over a Dosing Interval (ARAUC0-T)
Observed accumulation ratio based on area under the concentration-time curve over a dosing interval (ARAUC0-T) in Part B
Measured: Day 14
Part B: Observed Accumulation Ratio Based on Maximum Observed Concentration During the Dosing Interval (ARCmax)
Observed accumulation ratio based on maximum observed concentration during the dosing interval (ARCmax) in Part B
Measured: Day 14
Part C: Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose.
Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Measured: Screening to follow-up (Approximately 7 weeks)

Timeline

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

27 May 202121 Apr 2022

First posted1 Jun 2021
Study start27 May 2021
Primary completion21 Apr 2022
Study completion21 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04908800
Sponsor's protocol ID: KRPA218-T101
Status last verified: Mar 2023
First submitted: 27 May 2021
Last updated: 8 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Human, Phase I, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects, Including Food-Effect and Drug-drug Interaction With Itraconazole
ClinicalTrials.gov ID: NCT04908800
Acronym / sponsor ID: KRPA218-T101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Kyorin Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
Study start: 27 May 2021 (actual)
Primary completion: 21 Apr 2022 (actual)
Study completion: 21 Apr 2022 (actual)
First posted: 1 Jun 2021 (actual)
Results: Posted 8 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Part A single ascending dose (SAD) and Part B multiple ascending dose (MAD): KRP-A218	Experimental	Drug: KRP-A218Administration Route: Oral
Part A (SAD) and Part B (MAD): Placebo	Placebo comparator	Drug: PlaceboAdministration Route: Oral
Part C drug-drug interaction (DDI): KRP-A218 and itraconazole	Experimental	Drug: KRP-A218, Drug: itraconazoleAdministration Route: Oral

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female adults, between 20 and 55 years of age, inclusive.
Body weight ≥50 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
In good health, at Screening or Day -1 as assessed by the Investigator.
Females will not be pregnant or lactating, and females of childbearing potential will agree to use contraception and to not donate eggs (ova, oocytes). Males will agree to use contraception and to not donate sperm.
Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Key exclusion criteria (16 listed)

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.
Use or intend to use any prescription medications/products within 14 days or 5 half-lives (whichever is longer) prior to dosing, unless deemed acceptable by the Investigator.
Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KRP-A218KRP-A218 tablet	Drug	Part A single ascending dose (SAD) and Part B multiple ascending dose (MAD): KRP-A218, Part C drug-drug interaction (DDI): KRP-A218 and itraconazole
PlaceboPlacebo tablet	Drug	Part A (SAD) and Part B (MAD): Placebo
itraconazoleAlso: Sporanox10 mg/mL oral solution	Drug	Part C drug-drug interaction (DDI): KRP-A218 and itraconazole

Primary outcome

Part A: Number of Participants With Adverse Events
Time frame: Screening to follow-up (Approximately 6 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Part B: Number of Participants With Adverse Events
Time frame: Screening to follow-up (Approximately 8 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Part C: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: Days 1 to 11
The area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity) following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: Days 1 to 11
The area under concentration-time curve from time 0 extrapolated to last quantifiable concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Maximum Observed Concentration (Cmax)
Time frame: Days 1 to 11
The maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Time of the Maximum Observed Concentration (Tmax)
Time frame: Days 1 to 11
The time of the maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Days 1 to 11
The apparent terminal elimination half-life following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Apparent Total Clearance (CL/F)
Time frame: Days 1 to 11
The apparent total clearance following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Part C: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Days 1 to 11
The apparent volume of distribution during the terminal phase following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole

19 secondary outcomes

Part A: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: Day 1
Part A: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: Day 1
Part A: Maximum Observed Concentration (Cmax)
Time frame: Day 1
Part A: Time of the Maximum Observed Concentration (Tmax)
Time frame: Day 1
Part A: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Day 1
Part A: Apparent Total Clearance (CL/F)
Time frame: Day 1
Part A: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Day 1
Part B: Area Under the Concentration-time Curve Over a Dosing Interval (AUC0-τ)
Time frame: Days 1 and 14
Part B: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: Day 1
Part B: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: Days 1 and 14
Part B: Maximum Observed Concentration (Cmax)
Time frame: Days 1 and 14
Part B: Minimum Observed Concentration (Cmin)
Time frame: Day 14
Part B: Time of the Maximum Observed Concentration (Tmax)
Time frame: Days 1 and 14
Part B: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Days 1 and 14
Part B: Apparent Total Clearance (CL/F)
Time frame: Days 1 and 14
Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Days 1 and 14
Part B: Observed Accumulation Ratio Based on Area Under the Concentration-Time Curve Over a Dosing Interval (ARAUC0-T)
Time frame: Day 14
Part B: Observed Accumulation Ratio Based on Maximum Observed Concentration During the Dosing Interval (ARCmax)
Time frame: Day 14
Part C: Number of Participants With Adverse Events
Time frame: Screening to follow-up (Approximately 7 weeks)

Results and safety

Results posted to the registry on 8 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Placebo	12	12
Part A: 1 mg KRP-A218 (Fasted Male)	5	5
Part A: 3 mg KRP-A218 (Fasted/Fed Male)	6	6
Part A: 3 mg KRP-A218 (Fasted Female)	6	6
Part A: 6 mg KRP-A218 (Fasted Male)	6	6
Part A: 12 mg KRP-A218 (Fasted Male)	6	6
Part A: 21 mg KRP-A218 (Fasted Male)	6	6
Part B: Placebo	8	8
Part B: 2 mg KRP-A218	8	8
Part B: 4 mg KRP-A218	8	8
Part B: 8 mg KRP-A218	8	7
Part B: 11 mg KRP-A218	8	8
Part C: Drug-drug Interaction Study	12	12

Primary outcome: Part A: Number of Participants With Adverse Events

Time frame: Screening to follow-up (Approximately 6 weeks). Number. Unit: participants

Measure	Part A: Placebo n = 12	Part A: 1 mg KRP-A218 (Fasted Male) n = 5	Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1) n = 6	Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2) n = 6	Part A: 3 mg KRP-A218 (Fasted Female) n = 6	Part A: 6 mg KRP-A218 (Fasted Male) n = 6	Part A: 12 mg KRP-A218 (Fasted Male) n = 6	Part A: 21 mg KRP-A218 (Fasted Male) n = 6
Overall TEAEs	4	3	4	3	2	2	3	2
Serious TEAEs	0	0	0	0	0	0	0	0
TEAEs Leading to Discontinuation	0	0	0	0	0	0	0	0
TEAEs Leading to Death	0	0	0	0	0	0	0	0

Population analysed: Safety population

Primary outcome: Part B: Number of Participants With Adverse Events

Time frame: Screening to follow-up (Approximately 8 weeks). Number. Unit: participants

Measure	Part B: Placebo n = 8	Part B: 2 mg KRP-A218 n = 8	Part B: 4 mg KRP-A218 n = 8	Part B: 8 mg KRP-A218 n = 8	Part B: 11 mg KRP-A218 n = 8
Overall TEAEs	6	3	7	5	5
Serious TEAEs	0	0	0	0	0
TEAEs leading to discontinuation	0	0	0	1	0
TEAEs leading to death	0	0	0	0	0

Population analysed: Safety population

Primary outcome: Part C: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)

Time frame: Days 1 to 11. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone n = 12	Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole n = 12
Value	191 (23.9)	360 (25.0)

Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone vs Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole: Ratio of geometric least squares mean: 1.88 (90% CI 1.74 to 2.04)

Population analysed: Pharmacokinetic Population)

Primary outcome: Part C: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)

Time frame: Days 1 to 11. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone n = 12	Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole n = 12
Value	182 (22.8)	306 (23.5)

Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone vs Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole: Ratio of geometric least squares mean: 1.68 (90% CI 1.57 to 1.79)

Population analysed: Pharmacokinetic population

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Placebo	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part A: 1 mg KRP-A218 (Fasted Male)	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part A: 3 mg KRP-A218 (Fasted Female)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A: 6 mg KRP-A218 (Fasted Male)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A: 12 mg KRP-A218 (Fasted Male)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part A: 21 mg KRP-A218 (Fasted Male)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part B: Placebo	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Part B: 2 mg KRP-A218	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Part B: 4 mg KRP-A218	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Part B: 8 mg KRP-A218	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Part B: 11 mg KRP-A218	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part C: Drug-drug Interaction Study: 200 mg Itraconazole Alone	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoji Mimaki study chair

Kyorin Pharmaceutical Co.,Ltd

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KRP-A218 and itraconazole in people with Healthy, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in United Kingdom.

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 5 inclusion and 16 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 8 Jan 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 A: Number of Participants With Adverse Events (time frame: Screening to follow-up (Approximately 6 weeks)). 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 NCT04908800.

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 8 Jan 2024.