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Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects

NCT03929016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-12-20

No results posted yet for this study

Summary

This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the body and will also look at the safety and tolerability of the test medicine after a single dose. This is the first time the test medicine DNDI-0690 will be administered to humans.

Conditions

  • Visceral Leishmaniasis
  • Cutaneous Leishmaniases

Interventions

DRUG

DNDI-0690

capsules of 10, 100 and 200 mg

DRUG

Placebo of DNDI-0690

capsules of matching placebo

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Sharan Sidhu, MD · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2019-12-06
Completion
2020-07-02

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 NCT03929016 on ClinicalTrials.gov