Health TrialsbyHealthPanel

A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-85
SponsorAbbVie

About this trial

This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

Body weight > 45 kg at the time of screening and upon initial confinement.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Disqualifiers

History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness.

History of any clinically significant sensitivity or allergy to any medication or food.

Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Emraclidine

    Drug

    Oral tablets

  • Placebo

    Drug

    Oral tablets

Treatment groups

52 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Emraclidine or Placebo- Group 1Experimental treatment 2 interventions
Group B: Emraclidine or Placebo- Group 2Experimental treatment 2 interventions
Group C: Emraclidine or Placebo- Group 3Experimental treatment 2 interventions
Group D: Emraclidine or Placebo- Group 4Experimental treatment 2 interventions
Group E: Emraclidine or Placebo- Group 5Experimental treatment 2 interventions
Group F: Emraclidine or Placebo- Group 6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Adverse Events

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Time frame
Up to approximately 50 days
2

Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements

Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Time frame
Up to approximately 20 days
3

Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)

12-lead resting ECG will be recorded.

Time frame
Up to approximately 20 days
4

Number of Participants with Clinical Significant Change in Physical Examinations

Number of participants with clinical significant change in physical examinations will be assessed.

Time frame
Up to approximately 20 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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

AbbVie

Lead sponsor

Source ClinicalTrials.gov
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