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A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers

NCT05830799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-01-03

Study results available
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Summary

This is a single-centre, open-label, fixed-sequence trial to evaluate the impact of C21 on the exposure of CYP1A2, CYP2C9, CYP3A4 and P-gp substrates in healthy volunteers.

Conditions

  • Drug Interaction

Interventions

DRUG

Drug Drug Interaction

The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated

Sponsors & Collaborators

  • Vicore Pharma AB

    lead INDUSTRY

Principal Investigators

  • Björn Schultze, MD · CTC Clinical Trial Consultants AB

  • Måns Jergil, PhD · CTC Clinical Trial Consultants AB

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2023-05-11
Completion
2023-05-11

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830799 on ClinicalTrials.gov