Drug-drug Interaction Study of KL1333 in Healthy Subjects

NCT04643249 | Completed Phase 1

• 1 other identifier: KL1333 2020-103
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Mitochondrial Disease

Outcome Measures

Primary Outcomes (1)

• 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

  day 14

Secondary Outcomes (2)

• 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

  Day 14

• assessment of the safety and tolerability of KL1333 when coadministered with repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy subjects.

  Day 14

Study Arms (1)

Active

EXPERIMENTAL

Daily treatment

Drug: KL1333; Drug: Flurbiprofen; Drug: Dextromethorphan; Drug: Bupropion; Drug: Midazolam injection; Drug: Omeprazole; Drug: Caffeine; Drug: Repaglinide

Interventions

KL1333 DRUG

Tablet

Active

Flurbiprofen DRUG

Tablet

Active

Dextromethorphan DRUG

Syrap

Active

Bupropion DRUG

Tablet

Active

Midazolam injection DRUG

solution for injection

Also known as: Midazolam

Active

Omeprazole DRUG

Capsule

Active

Caffeine DRUG

Tablet or capsule

Active

Repaglinide DRUG

Tablet

Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abliva AB: lead

Study Sites (1)

Volunteer recruitment center Covance Leeds Covance Leeds

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Flurbiprofen; Dextromethorphan; Bupropion; Midazolam; Omeprazole; Caffeine; repaglinide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Xanthines; Purinones; Purines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects are treated in the same arm, but in a crossover manner.

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 25, 2020
• Study Start: November 10, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

GB (1)