INDV-2000 First in Human | NCT04413552

NCT04413552

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
UG3DA050308	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part I: INDV-2000	Experimental	Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics.	Drug: INDV-2000
Part I: Placebo	Placebo Comparator	Participants will receive a single dose of matching placebo.	Drug: Placebo
Part II: INDV-2000 Fasted/Fed	Experimental	Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I.	Drug: INDV-2000

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INDV-2000	Drug	INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.	Part I: INDV-2000 Part II: INDV-2000 Fasted/Fed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: Death Life-threatening In-patient hospitalization or prolongation of existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.	From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Clinically Significant Laboratory Findings	The investigator assessed abnormal laboratory values to determine clinical significance.	From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to verbalize understanding the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, and be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study interventions.
Must be considered a healthy male or non-childbearing female for Part I
For Part II, must be a healthy male who did not participate in Part I and willing to consume a high-fat meal.
Body mass index (BMI) within 18.0 to 30.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening)
Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from time of screening until 90 days after last dose of Investigational Medicinal Product (IMP). Additionally, male subjects must agree to not donate sperm during the study and for at least 90 days from last dose of IMP.

Exclusion Criteria:

Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator,
Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator,
Have a history of narcolepsy or other significant sleep disorders
Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes,
Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
Serious cardiac illness or other medical condition including, but not limited to: Uncontrolled arrhythmias; History of congestive heart failure (CHF); myocardial infarction < 6 months from receipt of first dose of IMP; uncontrolled symptomatic angina; corrected QT value (QTcF) > 450 msec for males and > 470 msec for females or history of prolonged QT syndrome; Have a blood pressure reading outside of the following range: systolic < 86 or > 149 mmHg; diastolic < 50 or > 94 mmHg
Current active hepatic or biliary disease. Subjects with cholecystectomy < 90 days prior to screening.
Regular alcohol consumption in males > 21 units per week and females > 14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
Positive test result for alcohol and/or drugs of abuse at screening or prior to the first IMP administration.
Current smokers and those who have smoked within the last 90 days. Current users of e-cigarettes and nicotine replacement products, and those who have used these products within the last 90 days.
Concurrent treatment or treatment with an investigational drug within 30 days prior to the first dose.
Blood donation of approximately 500 mL within 56 days or plasma donation within 7 days of screening.
Subjects who are taking, or have taken, any prescribed or over-the-counter drugs (other than 2 g per day acetaminophen, hormone replacement therapy, hormonal contraception) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study, as agreed by an Investigator and Sponsor's Medical Monitor.
Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges within 7 days prior to the IMP administration
Treatment with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) 3A4 within 30 days prior to first dose of IMP.
Known allergy or hypersensitivity to IMP or its excipients.
Any condition that, in the opinion of an Investigator, would interfere with evaluation of the IMP or interpretation of subject safety or study results.
Affiliated with, or a family member of, site staff directly involved in the study, or anyone with a financial interest in the outcome of the study.
Subjects who are unable, in the opinion of an Investigator, to comply fully with the study requirements.

Name	Affiliation	Role
Martin Kankam	Altasciences Company Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences Clinical Kansas		Overland Park	Kansas	66212	United States

Arm/Group Information

ID	Title	Description
FG000	Part I: INDV-2000 1 mg	Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.
FG001	Part I: INDV-2000 5 mg	Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.
FG002	Part I: INDV-2000 20 mg	Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.
FG003	Part I: INDV-2000 50 mg	Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.
FG004	Part I: INDV-2000 120 mg	Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.
FG005	Part I: INDV-2000 180 mg	Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.
FG006	Part I: INDV-2000 360 mg	Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.
FG007	Part I: INDV-2000 720 mg	Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.
FG008	Part I: Pooled Placebo	Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
FG009	Part II: INDV-2000 360 mg Fasted/Fed	Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part I: INDV-2000 1 mg	Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.
BG001	Part I: INDV-2000 5 mg	Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		Demographic data are reported separately for Part I and Part II.

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: Death Life-threatening In-patient hospitalization or prolongation of existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.	Participants who received at least one dose of study drug (safety population)	Posted		Count of Participants		Participants		From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part I: INDV-2000 1 mg	Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 10, 2020	Aug 19, 2022	Prot_001.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 30, 2021	Aug 19, 2022	SAP_002.pdf
ICF	No	No	Yes	Informed Consent Form	Jun 23, 2020	Apr 14, 2021	ICF_000.pdf

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders