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A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878

NCT03244228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-11-29

No results posted yet for this study

Summary

Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability.

Conditions

  • Healthy

Interventions

DRUG

HTL0016878

Oral solution

DRUG

Placebo - Concentrate

Matching placebo

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Nxera Pharma UK Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2019-09-23
Completion
2019-09-23

Countries

  • United Kingdom

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 NCT03244228 on ClinicalTrials.gov