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A FIH Study to Investigate the Safety, Tolerability and PK of P218

NCT02885506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-08-01

Study results available
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Summary

The First in Human (FIH) study is separated into two parts:

* The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).
* The second part is a food effect cohort with an open-labelled, randomized fed/fasted cross-over design.

The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics (PK) of P218 in healthy volunteers.

Conditions

Interventions

DRUG

Oral administration of P218 capsules

Oral administration of P218 capsules. The number of capsules is determined by the dose level of the cohort.

DRUG

Oral administration of P218 matching placebo

Oral administration of P218 matching placebo. The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Emilie Rossignol, PhD · Medicines for Malaria Venture

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2016-08-24
Primary Completion
2017-12-04
Completion
2017-12-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02885506 on ClinicalTrials.gov