A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers

Celltrion1 site in 1 country41 target enrollmentJuly 23, 2021

ConditionsHealth, Subjective

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Health, Subjective
Sponsor: Celltrion
Enrollment: 41
Locations: 1
Primary Endpoint: AUCτ,ss
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0901 and CTL0902 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.

Registry

clinicaltrials.gov

Start Date

July 23, 2021

End Date

October 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Celltrion

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject who weighs 50 kg or more (45 kg or more for women)
•A subject who does not have clinically significant congenital or chronic diseases
•A subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator
•A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of the investigational drug
•A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, the characteristics of the investigational drugs, and expected adverse reactions

Exclusion Criteria

•A subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them
•A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
•A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc)
•A subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration
•A subject who is judged ineligible for participation in this study by the principal investigator
•A female volunteer who is pregnant or lactating

Outcomes

Primary Outcomes

AUCτ,ss

Time Frame: predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

Cmax,ss

Time Frame: predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

Secondary Outcomes

Tmax,ss(predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose)
Cmin,ss(predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose)