ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity

NCT04890873 | Completed Phase 1 FDA Drug

• 1 other identifier: ERX1000-C-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the safety and tolerability of single and multiple oral doses of ERX1000 in obese subjects.

Conditions

Obesity

Keywords

ERX1000; Obesity

Outcome Measures

Primary Outcomes (13)

• Part A (Single Dose Group A9): Incidence and severity of adverse events (AEs)

  Day 1 up to end of study (Day 10)

• Part A (Single Dose Group A9): Incidence of clinical laboratory abnormalities

  Screening (Day -28) up to end of study (Day 10)

• Part A (Single Dose Group A9): Incidence of 12-lead electrocardiogram (ECG) abnormalities

  Screening (Day -28 to Day -2), Days 1, 3 and 10

• Part A (Single Dose Group A9): Incidence of vital sign abnormalities

  Screening (Day -28 to Day -2), Check-in (Day -1), Days 1, 3, 4, 5, 6 and 10

• Part A (Single Dose Group A9): Incidence of physical examination abnormalities

  Check-in (Day -1), Days 6 and 10

• Part B (Multiple Dose Group B5): Incidence of 12-lead electrocardiogram (ECG) abnormalities

  Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 4, 7, 10, 19, 25, 28, 30 and 37

• Part B (Multiple Dose Group B5): Incidence of vital sign abnormalities

  Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 19, 22, 25, 28, 30 and 37

• Part B (Multiple Dose Group B5): Incidence of physical examination abnormalities

  Check-in (Day -2), Days 30, 33 and 37

• Part B (Multiple Dose Group B6): Incidence of 12-lead electrocardiogram (ECG) abnormalities

  Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 8, 10, 15, 17, 22, 25, 29, 34 and End of Study (Day 41)

• Part B (Multiple Dose Group B6): Incidence of vital sign abnormalities

  Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 25, 27, 29, 34, 38 and End of Study (Day 41)

• Part B (Multiple Dose Group B6): Incidence of physical examination abnormalities

  Check-in (Day -2), Days 34, 38 and End of Study (Day 41)

• Part B (Multiple Dose Group B5 and Multiple Dose Group B6): Incidence and severity of adverse events (AEs)

  Day 1 up to end of study (For Group B5, Day 37 and for Group B6, Day 41)

• Part B (Multiple Dose Group B5 and Multiple Dose Group B6): Incidence of clinical laboratory abnormalities

  Screening (Day -28), Check-in (Day-2), Days 7, 14, 21, 28, 34 and End of Study (Day 41)

Secondary Outcomes (64)

• Part A (Single Dose Group A9): Plasma pharmacokinetic (PK) outcome endpoint of ERX1000, AUC0-t

  Day 1, 8 and 10

• Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, AUC0-∞

  Day 1, 8 and 10

• Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, AUC0-τ

  Day 1, 8 and 10

• Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Cmax

  Day 1, 8 and 10

• Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Ctrough

  Day 1, 8 and 10

Study Arms (2)

ERX1000

EXPERIMENTAL

ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.

Drug: ERX1000

Placebo

PLACEBO COMPARATOR

Reference product: Magnesium hydroxide carbonate powder prepared in an oral suspension

Drug: Placebo

Interventions

ERX1000 DRUG

ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension

ERX1000

Placebo DRUG

A suspension containing magnesium hydroxide carbonate in polysorbate

Also known as: Magnesium hydroxide carbonate

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
• Adult females and males, of any race, between 18 and 55 years of age, inclusive, at Screening.
• Females of non-childbearing potential, which is defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or with bilateral tubal ligation or Essure® (hysteroscopic bilateral tubal occlusion) with confirmation of occlusion of the fallopian tubes performed at least 3 months prior to Screening, or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause and follicle-stimulating hormone \[FSH\] level
• ≥ 40 mIU/mL). Males will agree to use contraception and refrain from sperm donation.
• Body mass index between 30.0 and 39.9 kg/m\^2, inclusive, at Screening.
• Glycosylated hemoglobin (HbA1c) level of \< 6.5% at Screening (test may be repeated once for confirmation of out-of-range values).
• Vital signs at Screening and Check-in as per the following ranges and stable (measured in a supine position after a minimum of 5 minutes of rest):
• Systolic blood pressure ≥ 90 and ≤ 140 mmHg
• Diastolic blood pressure ≥ 50 and ≤ 90 mmHg
• Pulse rate ≥ 50 and ≤ 100 bpm.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).

You may not qualify if:

• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dose administration on Day 1.
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• Obesity induced by known endocrine or genetic disorders (eg, Cushing syndrome, hypothyroidism, Prader Willi syndrome).
• Any previous surgical treatment or procedures with medical devices (such as insertion of lap band or gastric balloons) for obesity (excluding liposuction if performed \> 1 year prior to Check-in).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, which would increase the subject's risk of participation.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair \> 6 months prior to Screening will be allowed).
• History or evidence of underlying liver disease, including viral (hepatitis B and C) or alcoholic hepatitis, or confirmed diagnosis of nonalcoholic steatohepatitis (NASH); nonalcoholic fatty liver disease with qualifying liver function tests (LFTs) will be allowed.
• Gilbert's Syndrome (congenital non-hemolytic hyperbilirubinemia) or suspicion of Gilbert's Syndrome based on total and direct bilirubin.
• Laboratory results that exceed the following thresholds at Screening AND Check-in (laboratory tests may be repeated once for confirmation of out-of-range values) as specified:
• alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN)
• aspartate aminotransferase (AST) \> 1.5 × ULN
• gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin, or International Normalized Ratio (INR) \> ULN
• Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration \< 13.0 g/dL \[130 g/L\] for males, \< 11.0 g/dL \[110 g/L\] for females) at Screening or any other condition known to interfere with interpretation of HbA1c measurement
• Neutrophils \< 1.5 × 109/L deemed clinically significant by Investigator upon a confirmatory repeat
• Thyroid-stimulating hormone (TSH) level above the normal range, confirmed on repeat.

Sponsors & Collaborators

• ERX Pharmaceuticals: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Irene Mirkin, MD

  Labcorp Clinical Research Unit Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 18, 2021
• Study Start: October 17, 2019
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)