Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz

A Phase I, Open-label, Fixed-sequence, Two-period, Crossover, Drug-drug Interaction Study to Investigate the Effect of Efavirenz on the Pharmacokinetics of Ganaplacide and Lumefantrine Combination in Healthy Participants

ClinicalTrials.gov Identifier: NCT05330273

Novartis Reference Number: CKAF156A2107

Last Update: Nov 04, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This will assess the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination. Results from this study will provide guidance on prescribing ganaplacide and lumefantrine combination when co-administered with moderate inducers of CYP3A4.

Condition 
Malaria
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Apr 28, 2022
Completion date 
Nov 22, 2022
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
Ganaplacide
Period 1: 400 mg (4 x 100 mg tablets) for oral administration Period 2: 400 mg (4 x 100 mg tablets) for oral administration
Combination Product
Lumefantrine
Period 1: 480 mg (2 x 240 mg sachets) for oral administration Period 2: 480 mg (2 x 240 mg sachets) for oral administration
Drug
Efavirenz
Period 2: 600 mg (1 x 600 mg tablet) for oral administration once daily (q.d.)

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive, at Screening.
In good health as determined by medical history, physical examination, vital signs, ECG and clinical laboratory tests, at Screening.
Must weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 to 29.9 kg/m2 inclusive, at Screening.

Exclusion Criteria:

Known family history or presence of long QT syndrome.
Known history or current clinically significant arrhythmias.
Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) exceeding 1.2 x upper limit of normal (ULN) and total bilirubin ≥ 1.5 x ULN or any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at Screening or First Baseline.
History of psychiatric illness.
Score "yes" on item 4 or item 5 of the suicidal ideation section of the C-SSRS, if this ideation occurred in the past 6 months of Screening, or "yes" on any item of the suicidal behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years of Screening.
History or presence of seizures.
History or presence of duodenal ulcer, ulcerative colitis or Crohn's disease.
Presence of active or uncontrolled thyroid disease.

Additional protocol-defined inclusion / exclusion criteria may apply.

Study Locations

United Kingdom
Novartis Investigative Site
Recruiting
Belfast, BT9 6AD
Northern Ireland
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals

Have a question?

Call 1-888-669-6682 or email [email protected]