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

Sponsor
Celltrion (Industry)
Overall Status
Completed
CT.gov ID
NCT05009368
Collaborator
(none)
41
1
2
2.8
14.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug: Treatment A
  • Drug: Drug: Treatment B
  • Drug: Drug: Treatment C
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 23, 2021
Actual Primary Completion Date :
Oct 8, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A - Sequence AC

Treatment A in Period 1 and Treatment C in Period 2

Drug: Drug: Treatment A
CTL0901, single dose, daily, repeated oral administration for 4 days

Drug: Drug: Treatment C
CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days

Experimental: Arm B - Sequence BC

Treatment B in Period 1 and Treatment C in Period 2

Drug: Drug: Treatment B
CTL0902, single dose, daily, repeated oral administration for 7 days

Drug: Drug: Treatment C
CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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 Outcome Measures

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 H Plus Yangji Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celltrion
ClinicalTrials.gov Identifier:
NCT05009368
Other Study ID Numbers:
  • CT-L09-101
First Posted:
Aug 17, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 23, 2021