CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
Oral administration of P218 capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02885506
NCT02885506Phase 1Completed
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A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile and Food Effect of P218 in Healthy Adult Volunteers

Medicines for Malaria Venture·interventional·Posted Aug 31, 2016·Updated Aug 1, 2019

In Brief

A Phase 1 clinical trial evaluating Oral administration of P218 capsules and Oral administration of P218 matching placebo for Malaria. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited Kingdom
CollaboratorsRichmond Pharmacology Limited

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 31, 2016
Enrollment StartAug 24, 2016
Primary CompletionDec 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.8 years ago

Interventions

Oral administration of P218 capsulesdrug

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

Oral administration of P218 matching placebodrug

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.