PET Imaging Study to Evaluate the mGlu5r Occupancy Following ADX48621 (Dipraglurant) Administration

Completed · Phase 1

Conditions studied: Healthy

In brief

This is an open label study, non-randomized, positron emission tomography (PET)study investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy subjects using \[18F\]-FPEB as the radiotracer.

Key facts

Study ID

NCT02447640

Run by

Johns Hopkins University

People needed

12

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2018-08-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females, 18-60 years old
• BMI of 18-32 kg/m2
• Female subjects must meet one of the following criteria:Surgically sterile (e.g. hysterectomy, or bilateral oophorectomy, tubal ligation) for at least 6 months prior to screening or Postmenopausal (no menstrual bleeding for at least 1 year prior to screening and confirmed by a plasma FSH level of > 40 IU/L) or Non-pregnant, non- lactating women of child-bearing potential and practicing contraception (e.g. hormonal birth control, intra uterine device, condom and spermicide)
• Able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if…

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or any psychiatric disorder (as determined by the Investigator).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy and hernia repair will be allowed).
• Use of any tobacco-containing or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to consent.
• Poor peripheral venous access.
• Participation in any clinical drug study within 30 days prior to dosing.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.