A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects

Solid Tumor Clinical Trial

Official title:

A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508179
• Other study ID #: 7HP-101a
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2020
• Est. completion date: October 25, 2021

Study information

• Verified date: October 2021
• Source: 7 Hills Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects

Description:

This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.

Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.

Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.

Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy males between the ages of 18 and 45 years, inclusive

• Normal clinical chemistry, hepatic function, hematology, thyroid function

• Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg

• Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation

• Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) = 1.1, and positive Rubella: AI = 1.0

Exclusion Criteria:

• Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator

• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin

• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

• Current treatment or treatment within 30 days with another investigational medication

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 7HP349 Single Ascending Dose
Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
• 7HP349 Multiple Ascending Dose
Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
• Placebo Single Ascending Dose
Part A: Placebo Capsules, Single Ascending Dose (SAD)
• Placebo Multiple Ascending Dose
Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
• 7HP349 Food Effect
Part C: 7HP349 Capsules, Food Effect

Locations

Country	Name	City	State
United States	Frontage Clinical Services Inc.	Secaucus	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
7 Hills Pharma, LLC	Frontage Clinical Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria	Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests	17 days
Secondary	Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)	Determination of maximum plasma concentration (Cmax)	17 days
Secondary	Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD)	Determination of plasma exposure (AUClast and/or AUCinf)	17 days
Secondary	Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)	Determination of exposure in urine	17 days
Secondary	Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)	Determination of renal clearance (CLr)	17 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals	Fed prandial state, determination of maximum plasma concentration (Cmax)	28 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals	Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf)	28 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals	Fasted prandial state, determination of maximum plasma concentration (Cmax)	28 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals	Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf)	28 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals	Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax	28 days
Secondary	Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals	Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf	28 days