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Trial record 2 of 3 for:    KL1333

Drug-drug Interaction Study of KL1333 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04643249
Recruitment Status : Completed
First Posted : November 25, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Abliva AB

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

Condition or disease Intervention/treatment Phase
Mitochondrial Disease Drug: KL1333 Drug: Flurbiprofen Drug: Dextromethorphan Drug: Bupropion Drug: Midazolam injection Drug: Omeprazole Drug: Caffeine Drug: Repaglinide Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Intervention Model Description: All subjects are treated in the same arm, but in a crossover manner.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 10, 2020
Actual Primary Completion Date : December 17, 2020
Actual Study Completion Date : December 17, 2020


Arm Intervention/treatment
Experimental: Active
Daily treatment
Drug: KL1333
Tablet

Drug: Flurbiprofen
Tablet

Drug: Dextromethorphan
Syrap

Drug: Bupropion
Tablet

Drug: Midazolam injection
solution for injection
Other Name: Midazolam

Drug: Omeprazole
Capsule

Drug: Caffeine
Tablet or capsule

Drug: Repaglinide
Tablet




Primary Outcome Measures :
  1. Determination of the effect of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects. [ Time Frame: day 14 ]
    Area under the curve AUC


Secondary Outcome Measures :
  1. 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 [ Time Frame: Day 14 ]
    Area under the curve AUC

  2. assessment of the safety and tolerability of KL1333 when coadministered with repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects. [ Time Frame: Day 14 ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females, of any race, between 18 and 65 years of age, inclusive.
  2. Weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive.
  3. 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.
  4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
  5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
  6. Able to perform all protocol-specified assessments and comply with the study visit schedule.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. History of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes.
  4. 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).
  5. 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.
  6. History of clinically significant illness or surgery within 4 weeks prior to screening, as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643249


Locations
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United Kingdom
Volunteer recruitment center Covance Leeds Covance Leeds
Leeds, United Kingdom
Sponsors and Collaborators
Abliva AB
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Responsible Party: Abliva AB
ClinicalTrials.gov Identifier: NCT04643249    
Other Study ID Numbers: KL1333 2020-103
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitochondrial Diseases
Metabolic Diseases
Repaglinide
Flurbiprofen
Midazolam
Dextromethorphan
Caffeine
Bupropion
Omeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists