A Pharmacokinetic Study of PLENVU® in Healthy Subjects

NCT03437265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-11-29

Study results available
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Summary

This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.

Conditions

  • Pharmacokinetic

Interventions

DRUG

PLENVU powder for oral solution

PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY
  • Norgine

    lead INDUSTRY

Principal Investigators

  • Philip Evans, MBChB, MRCS · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2020-10-05
Completion
2020-10-05
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT03437265 on ClinicalTrials.gov