Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort

An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04097704

Enrollment

Registered

2019-09-20

Start date

2019-09-04

Completion date

2019-11-01

Last updated

2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency

Keywords

Hepatic impairment, CC-90007-CP-003, Healthy Subject

Brief summary

This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study. Approximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Each subject must satisfy all of the following criteria to be enrolled in this study: 1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Subject participated in the CC-90007-CP-003 study.

Exclusion criteria

The presence of any of the following will exclude a subject from enrollment: 1. Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has any condition that confounds the ability to interpret data from the study. Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria	Day 1	DNA Quality

Secondary

Measure	Time frame	Description
Adverse Events (AEs)	Time from ICF to Day 1	Number of participants with adverse event

Countries

United States

Outcome results