A prospective, open label study to evaluate the safety and pharmacokinetics of ML-004-ER under fed and fasted conditions in healthy adult volunteers
A Phase 1 Open Label Crossover Study to assess safety and bioavailability of ML-004-ER under Fasted and Fed Conditions in Adult Healthy Volunteers
MapLight Therapeutics Inc
12 participants
May 12, 2021
Interventional
Conditions
Summary
This is a Phase 1 Open Label Crossover study of ML-004-ER, an extended release drug product (intended for use in the management of patients with autism spectrum disorder), in adult healthy volunteers that characterise the bioavailability and pharmacokinetic profile of single dose under fasted and fed conditions. Each participants will receive a single oral dose of ML-004-ER prior to or following a designated meal, and the pharmacokinetic profile will be assessed for up to 24 hours to assess the impact food has on the rate and extent of absorption.
Eligibility
Inclusion Criteria9
- Healthy adult male and female participants ages 18 to 45 years (inclusive).
- Negative for drugs of abuse at Screening.
- Body mass index (BMI) 21 to 32 kg/m2, inclusive.
- Contraception:
- a. If female, is either:
- i. Not of childbearing potential, defined as postmenopausal (>/= 12 continuous months of amenorrhea with no other cause than menopause) or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, participants who practice sexual abstinence as part of their preferred and usual lifestyle, or participants in same-sex relationships.
- ii. Of childbearing potential and participates in any activity associated with risk of pregnancy and is practicing at least 1 highly effective method of birth control (e.g., intrauterine device, oral or parenteral contraceptives, a vasectomized partner, abstinence from sexual intercourse). The Principal Investigator (PI) will discuss with the participant the option of practicing more than 1 of the above methods for the duration of the study through to 90 days post last dose.
- b. If male and not surgically sterile, and partner is of childbearing potential, participant agrees to use male condom with spermicide (double-barrier method) for the duration of the study. Abstinence of sexual intercourse is an acceptable method of birth control if it is used continuously for the duration of the study.
- Ability to participate, willingness to give written informed consent, and willingness to comply with the study restrictions.
Exclusion Criteria21
- Have taken, with 4 weeks of Screening or Intake, any of the following:
- Selective Serotonin Reuptake Inhibitors (SSRIs)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs).
- MAO-A inhibitors
- Another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication (example: dihydroergotamine or methysergide), including St John’s wort
- Are taking cimetidine and are unable to discontinue use of cimetidine from Screening until the End of Study.
- Significant current use of tobacco products, as judged by the Investigator.
- Have a diagnosis or clinical history of cardiac, cerebrovascular or peripheral vascular disease, including Prinzmetal’s angina and Wolff-Parkinson-White syndrome
- Screening or Intake systolic blood pressure >/=140mmHg (confirmed with repeat readings), or a clinical history of uncontrolled or severe hypertension.
- Evidence of clinically significant ECG abnormalities at Screening or Baseline, in the clinical judgement of the Investigator.
- Screening or Intake liver function tests that demonstrate an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal.
- Diagnosed with, or clinical history of epilepsy or structural brain lesions reported at screening.
- Diagnosed with, or clinical history of migraines, with or without aura reported at screening.
- Known history of alcohol use disorder or other substance use disorder within 6 months prior to Screening.
- Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening.
- Pregnant or lactating female participants.
- History of galactose intolerance (i.e., Lapp lactase deficiency or glucose-galactose malabsorption).
- Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
- Participated in the Phase 1 Pharmacokinetic Multiple Ascending Dose study (MAP-ZOL-HV-001).
- Other medical or psychiatric condition which, in the opinion of the Investigator, would place the participant at increased risk of safety/tolerability issues and/or would preclude obtaining voluntary consent and/or would confound the interpretation of the primary outcome measures in the study.
- Unwillingness or inability to comply with the study protocol, (including abstaining from all tobacco products during the dosing period and following a strict diet regime), for any other reason.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
All participants in this study will receive 2 single doses of 24mg ML-004 extended-release oral tablets and 1 single dose of 20mg immediate-release oral tablets under fed (meal containing approximately 50% fat consumed 1 hour prior to dosing) or fasted (meal consumed 12 hours prior to dosing) conditions. The immediate-release dose will be administered on Day 1 and the extended-release doses will be administered on Day 2 (24 hours after the previous dose) and Day 4 (48 hours after the previous dose). The dosing schedule is the same for all participants.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621000461897