SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Radioactive Tablet (Part 2 Only); Drug: Placebo; Drug: AMT-126

• Registration Number: NCT05476107
• Lead Sponsor: Applied Molecular Transport

Brief Summary

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Detailed Description

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Study Timeline

• Study Start: 2021-02-26
• Primary Completion: 2022-03-26
• Study Completion: 2022-03-26
• Study First Submitted: 2022-06-22
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy male subjects and female subjects of NOCBP.
• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
• Contraception requirements for male & female subjects.

Exclusion Criteria

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
• Evidence of current SARS-CoV-2 or COVID infection.
• Women of child-bearing potential.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Radioactive Tablet (Part 2 only)	Radioactive Tablet (Part 2 Only)	oral radioactive tablet for scintigraphic analysis
Placebo	Placebo	oral placebo
AMT-126	AMT-126	oral AMT-126

Primary Outcome Measures

Name	Time	Method
To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)	5 days	Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)
Incidence of Treatment-emergent adverse events (safety and tolerability)	5 days	Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
To assess pharmacokinetics of AMT-126 in healthy volunteers	5 days	Assess PK parameters (i.e. Cmax) as applicable for AMT-126

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Ruddington, Nottingham, United Kingdom