Drug-drug Interaction Study of KL1333 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2020-12-17

Brief Summary

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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

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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.

Conditions

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Mitochondrial Disease

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Volunteer recruitment center Covance Leeds Covance Leeds

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KL1333 2020-103

Identifier Type: -

Identifier Source: org_study_id

Drug-drug Interaction Study of KL1333 in Healthy Subjects

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Active

KL1333

Flurbiprofen

Dextromethorphan

Bupropion

Midazolam injection

Omeprazole

Caffeine

Repaglinide

Interventions