A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MIV-711

• Registration Number: NCT03443453
• Lead Sponsor: Medivir

Brief Summary

This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-19
• Study First Submitted: 2018-01-22
• Status Verified: 2018-02
• Primary Completion: 2018-02-17
• Study Completion: 2018-02-17
• Study First Submitted QC: 2018-02-21
• Last Update Submitted: 2018-02-21
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MIV-711 CDAB	MIV-711	Subjects will first receive the capsule formulation under fasted conditions (C)followed by the capsule formulation administered under fed conditions (D). Thereafter they will receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B).
MIV-711 ABCD	MIV-711	Subjects will first receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Thereafter they will receive the capsule formulation under fasted conditions (C) followed by the capsule formulation administered under fed conditions (D).

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Maximum observed concentration (Cmax)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time to reach maximum observed concentration (Tmax)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Apparent terminal elimination rate constant (Kel)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Apparent terminal elimination half-life (T½)	0 to 72 hours post dose	The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.

Secondary Outcome Measures

Name	Time	Method
The number and severity of AEs/SAE	from study start until 7+/-2 days after the last study drug administration	Safety and tolerability of MIV-711 measured by number and severity of AEs/SAEs
The number of clinically significant abnormal lab results	from study start until 7+/-2 days after the last study drug administration	Safety and tolerability of MIV-711 measured by number of clinical significant abnormal lab results.
The number of clinically significant ECG abnormalities	from study start until 7+/-2 days after the last study drug administration	Safety and tolerability of MIV-711 measured by number of clinical significant ECG abnormalities.
The number of clinically significant physical examination abnormalities	from study start until 7+/-2 days after the last study drug administration	Safety and tolerability of MIV-711 measured by number of clinical significant physical examination abnormalities.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States