Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects

Inversago Pharma

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic

Treatments: Drug: INV-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04531150

INV101-CL-101

Details and patient eligibility

About

Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.

Enrollment: 40 patients

Sex: All

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male or female
• Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
• Non- or ex-smoker
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion criteria

• Female who is pregnant or lactating
• Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Subjects will be randomized to receive either placebo or 20 mg INV-101

Treatment:

Drug: Placebo

Drug: INV-101

Cohort 2

Experimental group

Description:

Subjects will be randomized to receive either placebo or 80 mg INV-101

Treatment:

Drug: Placebo

Drug: INV-101

Cohort 3

Experimental group

Description:

Subjects will be randomized to receive either placebo or 160 mg INV-101

Treatment:

Drug: Placebo

Drug: INV-101

Cohort 4

Experimental group

Description:

Subjects will be randomized to receive either placebo or 320 mg INV-101

Treatment:

Drug: Placebo

Drug: INV-101

Cohort 5

Experimental group

Description:

Subjects will be randomized to receive either placebo or 500 mg INV-101

Treatment:

Drug: Placebo

Drug: INV-101