Back to resultsDrug-drug Interaction Study of KL1333 in Healthy Subjects
Primary Purpose
Mitochondrial Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
KL1333
Flurbiprofen
Dextromethorphan
Bupropion
Midazolam injection
Omeprazole
Caffeine
Repaglinide
Sponsored by
About this trial
This is an interventional treatment trial for Mitochondrial Disease
Eligibility Criteria
Inclusion Criteria:
- Males or females, of any race, between 18 and 65 years of age, inclusive.
- Weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinaemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Able to perform all protocol-specified assessments and comply with the study visit schedule.
Exclusion Criteria:
- 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.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including KL1333 or its excipients, unless approved by the investigator.
- History of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs including cholecystectomy (uncomplicated appendectomy and hernia repair will be allowed).
- History of malignancy of any organ system other than localised basal cell carcinoma of the skin, treated or untreated, within 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
- History of clinically significant illness or surgery within 4 weeks prior to screening, as determined by the investigator.
Sites / Locations
- Volunteer recruitment center Covance Leeds Covance Leeds
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Daily treatment
Outcomes
Primary Outcome Measures
Determination of the effect of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects.
Area under the curve AUC
Secondary Outcome Measures
evaluation of the single-dose PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen administered alone and in the presence of KL1333 in healthy subjects
Area under the curve AUC
assessment of the safety and tolerability of KL1333 when coadministered with repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04643249
Brief Title
Drug-drug Interaction Study of KL1333 in Healthy Subjects
Official Title
A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
December 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abliva AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects
Detailed Description
This will be a Phase I, open-label, fixed-sequence, crossover study to investigate the effect of coadministration of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until discharge on Day 19. Subjects will return to the CRU for a follow-up visit 5 to 7 days after the last dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
All subjects are treated in the same arm, but in a crossover manner.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Daily treatment
Intervention Type
Drug
Intervention Name(s)
KL1333
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
Syrap
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Midazolam injection
Other Intervention Name(s)
Midazolam
Intervention Description
solution for injection
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
Capsule
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Tablet or capsule
Intervention Type
Drug
Intervention Name(s)
Repaglinide
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Determination of the effect of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects.
Description
Area under the curve AUC
Time Frame
day 14
Secondary Outcome Measure Information:
Title
evaluation of the single-dose PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen administered alone and in the presence of KL1333 in healthy subjects
Description
Area under the curve AUC
Time Frame
Day 14
Title
assessment of the safety and tolerability of KL1333 when coadministered with repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects.
Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males or females, of any race, between 18 and 65 years of age, inclusive.
Weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive.
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinaemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator.
Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Able to perform all protocol-specified assessments and comply with the study visit schedule.
Exclusion Criteria:
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.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including KL1333 or its excipients, unless approved by the investigator.
History of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs including cholecystectomy (uncomplicated appendectomy and hernia repair will be allowed).
History of malignancy of any organ system other than localised basal cell carcinoma of the skin, treated or untreated, within 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
History of clinically significant illness or surgery within 4 weeks prior to screening, as determined by the investigator.
Facility Information:
Facility Name
Volunteer recruitment center Covance Leeds Covance Leeds
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
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Drug-drug Interaction Study of KL1333 in Healthy Subjects
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