A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers

NCT05009368 | Completed Phase 1

• 1 other identifier: CT-L09-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (2)

• AUCτ,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

• Cmax,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

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm A - Sequence AC

EXPERIMENTAL

Treatment A in Period 1 and Treatment C in Period 2

Drug: Drug: Treatment A; Drug: Drug: Treatment C

Arm B - Sequence BC

EXPERIMENTAL

Treatment B in Period 1 and Treatment C in Period 2

Drug: Drug: Treatment B; Drug: Drug: Treatment C

Interventions

Drug: Treatment A DRUG

CTL0901, single dose, daily, repeated oral administration for 4 days

Arm A - Sequence AC

Drug: Treatment B DRUG

CTL0902, single dose, daily, repeated oral administration for 7 days

Arm B - Sequence BC

Drug: Treatment C DRUG

CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days

Arm A - Sequence AC; Arm B - Sequence BC

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 17, 2021
• Study Start: July 23, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 15, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

KR (1)