Health TrialsbyHealthPanel

Phase 1 Study of Oral MG001

ConditionSafety and Tolerability in Healthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Institute on Drug Abuse (NIDA)

About this trial

This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. The purpose of this study is to understand how safe MG001 is, how well it is tolerated, and how the body processes it. About 32 healthy adult volunteers, both men and women, will take part. Before joining, participants will undergo screening tests up to four weeks in advance to make sure they are eligible and healthy enough. On the day before dosing, participants will be admitted to the clinic for final health checks, and those who qualify will be randomly assigned-by chance, like flipping a coin-to receive either a single dose of MG001 or a placebo (an inactive substance). Neither the participants nor the staff giving the medicine will know which one is given. The study drug will be administered after at least 10 hours of fasting, and participants will then remain in the research clinic under close medical observation for three nights, until Day 4. During this time, doctors and nurses will monitor participants' health, look for any side effects, and collect blood samples to see how MG001 moves through the body. A follow-up clinic visit on Day 7 will provide one last check-in and blood test. This design helps researchers gather important first information on the safety and tolerability of MG001, while protecting the health and well-being of participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is a healthy male or female volunteer between 18 and 65 years of age, inclusive, at the time of consent.

Has a body mass index (BMI) within the range of 18.0 to 32.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.

Has a recent history of oral opioid use , defined as using prescription or recreational oral opioids at least once during the 30-day period preceding screening.

Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Disqualifiers

Has any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs (including hemoglobin saturation assessed by pulse oximetry, RR, HR, BP, oral body temperature ), or ECGs that contraindicate participation in the study. This includes but is not limited to history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI) , pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.

Has clinically significant psychiatric symptoms and/or psychiatric comorbidities (schizophrenia, bipolar disorders, mania, unipolar depression, disruptive behaviors, etc.), or a history of such within one year of screening. Psychiatric assessment will be conducted by a Qualified Mental Health Professional using the Mini-International Neuropsychiatric Interview (MINI).

Any lifetime history of serious or recurrent suicidal behavior.

Previous history of suicidal behaviors in the past 10 years.

Trial design

Design model

Sequential

Treatments tested in this trial

  • mitragynine

    Drug

    Mu opioid receptor partial agonist

  • Placebo

    Drug

    Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.

Treatment groups

32 Participants
are divided into 5 treatment groups
Group A: 25 mg doseExperimental treatment 1 intervention
Group B: 50 mg doseExperimental treatment 1 intervention
Group C: 75 mg doseExperimental treatment 1 intervention
Group D: 100 mg doseExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants

The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity. Events will be identified either through subject self-report or clinically significant abnormal findings on: (i) Physical examination (ii) Vital signs assessments (heart rate (BPM), blood pressure (mmHg), respiration rate (BPM), hemoglobin saturation (%) and temperature (F)) (iii) ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist (iv) pupil constriction (mm) (v) sedation as measured by VAS (score) and MOAA/S (score (vi) Clinical Laboratory Assessments

Time frame
4 days in clinic, follow-up on day 7

Secondary outcomes

1

Cmax

maximum observed plasma concentration (ng/mL)

Time frame
144 hours
2

AUC

area under the concentration-time curve (mg\*h/L)

Time frame
144 hours
3

Tmax

time of maximum observed plasma concentration (hours)

Time frame
144 hours
4

half-life (t1/2)

MG001 elimination half-life (hours)

Time frame
144 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute on Drug Abuse (NIDA)

Lead sponsor

Altasciences Company Inc.

Collaborator

Technical Resources International, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: