Overview

Effect of Hydroxychloroquine Sulphate in Healthy Lean Females

Status:
Unknown status
Trial end date:
2019-10-01
Target enrollment:
0
Participant gender:
Female
Summary
The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Universitaire Ziekenhuizen Leuven
Treatments:
Hydroxychloroquine
Criteria
Inclusion Criteria:

- Subject is female between 18 and 65 years of age.

- Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3
consecutive months at the start of the study and keeps a stable weight during the
study visits.

- Subject is allowed to take 2 Plaquenil capsuls for one visit with a maximal dose of
6.5 mg hydroxychloroquine sulphate per kg bodyweight.

- Women of child-bearing potential agree to apply during the entire duration of the
trial a highly effective method of birth control, which is defined as those which
result in a low failure rate (i.e., less than 1% per year) when used constantly and
correctly such as implants, injectables, combined oral contraceptive method, or some
intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of
non-childbearing potential may be included if surgically sterile (tubal ligation or
hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.

- Subject understands the study procedures and agrees to participate in the study by
giving written informed consent.

Exclusion Criteria:

- Subject is under age of legal consent, male, pregnant or breastfeeding.

- Subject with a BMI ≥ 18 kg/m² or BMI ≤ 25 kg/m².

- Subject has current symptoms or a history of gastrointestinal or other significant
somatic or psychiatric diseases or drug allergies.

- Subject has diabetes.

- Subject has a significant heart, lung, liver or kidney disease.

- Subject has a QT-interval > 450 ms.

- Subject has any history of a neurological disorder.

- Subject has a history of abdominal surgery. Those having undergone a simple
appendectomy more than 1 year prior to the screening visit may participate.

- Subject has retinopathy.

- Subject suffers from psoriasis.

- Subject has porphyria.

- Subject shows abnormal eating behavior or has an eating disorder.

- History or current use of drugs that can affect glycaemia, gastrointestinal function,
motility or sensitivity or gastric acidity.

- History or current use of centrally acting medication, including antidepressants,
antipsychotics and/or benzodiazepines (in the last year before screening visit).

- Subject consumes excessive amounts of alcohol, defined as >14 units per week.

- Subject is currently (defined as within approximately 1 year of the screening visit) a
regular or irregular user (including "recreational use") of any illicit drugs
(including marijuana) or has a history of drug (including alcohol) abuse. Further,
patient is unwilling to refrain from the use of drugs during this study.

- High caffeine intake (> 500 ml coffee daily or equivalent).

- Inability or unwillingness to perform all of the study procedures, or the subject is
considered unsuitable in any way by the principal investigator.

- Recent participation (<30 days) or simultaneous participation in another clinical
study.

- Subjects with lactose intolerance.

- Subjects with quinine allergy.